Techniques for forming a modular lead

ABSTRACT

Systems, devices, and techniques are disclosed for forming an elongate lead body module of a modular lead. The method may comprise rotating a mandrel, wherein the mandrel extends through a through-hole of a conductor hub, wherein each conductor of a plurality of conductors extend through a respective channel of a plurality of channels of the conductor hub, wherein each conductor of the plurality of conductors extends from a respective bobbin of plurality of bobbins to the channels, wherein the plurality of bobbins are coupled to a carriage, the carriage defining a central opening through which the mandrel passes. The method may comprise moving the carriage away from the conductor hub along a length of the mandrel while the mandrel rotates causing the conductors to coil around the mandrel.

This application claims the benefit of U.S. Provisional Application Ser.No. 62/435,618, filed on Dec. 16, 2016, the entire content of which isincorporated herein by reference.

TECHNICAL FIELD

This disclosure relates to medical device systems including one or moreleads.

BACKGROUND

Medical devices may be used to deliver therapy to a patient to treatsymptoms or conditions such as chronic pain, seizure disorders (e.g.,epilepsy), heart arrhythmias (e.g., fibrillation), tremor, Parkinson'sdisease, other types of movement disorders, obesity, mood disorders,urinary or fecal incontinence, or other types of symptoms or conditions.The therapy may be electrical stimulation therapy. Medical devices, suchas implantable medical devices (IMDs), may be used for therapies such asdeep brain stimulation (DBS), spinal cord stimulation (SCS), sacralneuromodulation, pelvic stimulation, gastric stimulation, peripheralnerve stimulation, cardiac stimulation, functional electricalstimulation, or other types of stimulation.

A medical device may include one or more leads carrying one or moreelectrodes. The medical device may deliver the electrical stimulationtherapy to one or more target tissue sites within the patient and/orsense one or more electrical signals via the lead.

SUMMARY

In some examples, the disclosure describes devices and systems includingmodular medical leads, as well as techniques and systems for making andusing such modular leads. Examples may include therapy systems (e.g.,medical device systems) that employ a modular lead to deliver electricalstimulation therapy and/or sense electrical signals of the patient totreat a patient condition. A modular lead may include two or moredistinct modules that may be manufactured independent of each other andsubsequently joined to each other to form a lead as desired. When therespective modules are assembled to form a modular lead, the modularmedical lead may be configured to be coupled to a medical device (e.g.,an IMD) to deliver electrical stimulation to a tissue of a patientand/or sense electrical signals via one or more electrodes of themodular lead. The one or more electrodes may be electrically coupled tothe medical device via one or more conductors extending distally withina lead body to the electrodes from one or more proximal electricalcontacts.

In one example, a modular lead may include a lead body module includinga plurality of conductors in a coiled configuration (also may bereferred to as a coiled “arrangement”) extending along a length of thelead. The plurality of conductors may be electrically isolated from eachother in the lead body module to define a plurality of isolatedconductive paths. The lead body module may also include a conductor hub(also may be referred to as a “distribution hub,” a “starting hub” or a“hub”) at one or more end portions of the lead body module. Theconductor hub may be mechanically coupled to the plurality of coiledconductors to fix the ends of the conductors relative to each other in adesired arrangement (e.g., as opposed to being loose ends extending froma coiled portions). For example, each of the plurality of conductors mayextend through a corresponding channel or other coupling feature of thehub located near an end of the lead body module along a desired path andposition such that the distal ends of the respective conductors extendfrom the end of the hub in a desired direction with a desired spacingbetween the respective conductors.

In some examples, the arrangement of conductor ends extending from thehub may be selected such that the plurality of conductors may be alignedwith corresponding conductive portions of another lead module to becoupled to the end of the lead body module, e.g., without aninterconnector between the respective modules. Examples of such anadditional lead module may include an electrode module or a connectormodule. In some examples, an electrode module includes a plurality ofelectrodes defining conductive surfaces configured to deliver electricalstimulation to a target site of the patient and/or sense electricalsignal of the patient. The electrode module may be coupled to the leadbody module via the plurality of conductors that run through theconductor hub in a configuration in which each of the respectiveconductors of the plurality of conductors of the lead body module areelectrically coupled to a corresponding electrode of the electrodemodule. Likewise, for example, a connector module may include aplurality of electrical connectors configured to be coupled to acorresponding electrical connector of a medical device. The connectormodule may be coupled to the lead body module via the plurality ofconductors that run through the conductor hub in a configuration inwhich each of the respective conductors of the plurality of conductorsof the lead body module are electrically coupled to a correspondingelectrical connector of the connector module. In some examples, amodular lead may include a connector module electrically connected to anelectrode module via the elongate lead body module.

Additionally, examples of the disclosure relate to techniques andsystems that may be used to manufacture an elongate lead body module.For example, during the manufacturing process, a plurality of conductors(e.g., each from a separate spool) may be first mechanically coupled toa conductor hub (referred to also as a starting hub) at a starting endand then the conductors may be wound about a mandrel using a winder toform a coiled portion of a desired length for the elongate lead bodymodule. Once the wound coil section is complete, another conductor hubmay be used to fix the conductors at the finishing end of the newlycoiled conductors from the winder. In some examples, a stabilizer hubmay be utilized in a multi-step process in which the conductors areinitially mated with the stabilizer hub, which controls the unwinding ofthe coiled conductors (e.g., in terms of speed, amount, etc.) duringmanufacturing spring back of the coil and keeps the conductors in adesired arrangement. Subsequently, the conductors may be transferredfrom the stabilizer hub to a final distribution hub in the arrangementdefined by the stabilizer hub.

In one aspect, the disclosure is directed to a modular medical leadsystem comprising an elongate lead body module including a plurality ofcoiled electrical conductors extending from a first end to a second endof the elongate lead body module, and a conductor hub adjacent the firstend of the elongate lead body module. In some examples, one or moreconductors (e.g., the plurality of conductors) may be in a straightarrangement or a sinusoidal arrangement. The plurality of conductors maybe electrically isolated from one another and mechanically coupled tothe conductor hub such that the plurality of conductors may be in afixed arrangement relative one another. A first end of the conductor hubmay be nearer the first end of the elongate lead body module than asecond end of the conductor hub. Each of the plurality of conductors mayextend from the first end to the second end of the conductor hubrelative a longitudinal axis of the elongate lead body module such thata portion of the conductors extend beyond the first end of the conductorhub. For each conductor, the portion of the conductor that extendsbeyond the first end of the conductor hub is configured to be coupled toa respective electrical conductor of a lead end module to allowrespective electrical signals to be conducted between the respectiveconductors of the lead end module and the conductors of the elongatelead body module.

In another aspect, the disclosure is directed to medical device systemcomprising a modular medical lead system described herein and a medicaldevice. The medical device may be configured to at least one of deliverelectrical stimulation to a patient or sense electrical signal of thepatient via the plurality of conductors.

In another aspect, the disclosure is directed to a method may compriseat least one of delivering electrical stimulation to a patient orsensing electrical signals of the patient via a medical device systemdescribed herein.

In another aspect, the disclosure is directed to a method comprisingforming a modular lead system described herein, wherein forming themodular lead system includes coiling or arranging the plurality ofelectrical conductors; and mechanically coupling the plurality ofelectrical conductors to the conductor hub such that the plurality ofconductors are in a fixed arrangement relative one another.

In another aspect, the disclosure is directed to a conductor hub for amodular medical lead system comprising a hub body including athrough-hole extending from a first end of the hub body to a second endof the hub body. The conductor hub may include a plurality of channelspositioned around the conductor hub. Respective longitudinal axes of theplurality of channels may be substantially parallel to a longitudinalaxis of the conductor hub. The plurality of channels may be positionedat a common radius from the longitudinal axis of the conductor hub.

In another aspect, the disclosure is directed to a method for forming anelongate lead body module of a modular lead, the method comprisingrotating a mandrel. The mandrel may extend through a through-hole of aconductor hub, wherein a plurality of conductors may extend through arespective plurality of channels of the conductor hub, the conductorsmay extend from a respective plurality of bobbins to the channels,wherein the bobbins may be coupled to a carriage, the carriage maydefine a central opening through which the mandrel passes. The methodmay include moving the carriage away from the conductor hub along alength of the mandrel while the mandrel rotates causing the conductorsto coil around the mandrel.

In another aspect, the disclosure is directed to a method for forming amodular lead comprising coiling a plurality of electrical conductorsaround a mandrel, wherein the mandrel may be coupled to a conductor hub,wherein the conductors may be mechanically coupled to the conductor hubsuch that the plurality of conductors may be in a fixed arrangementrelative to one another. Coiling the conductors may include coiling theconductors along a length of the mandrel, wherein the plurality ofconductors extend may from a respective plurality of bobbins coupled toa carriage, the carriage may define a central opening through which themandrel extends. Coiling the conductors may include moving at least oneof the mandrel and the carriage relative to each other angularly andlongitudinally, wherein the relative longitudinal movement may occuralong a longitudinal axis of the mandrel, and wherein the relativeangular movement may occur such that an orientation of the mandrel andan orientation of the carriage rotate relative to each other.

In another aspect, the disclosure is directed to a system for assemblinga modular medical lead, the system comprising a winder station includinga mandrel extending from a first section to a second section of thewinder station, a motor coupled to the mandrel in the first section, acarriage mount configured to couple to a carriage, wherein the mandrelextends through an opening defined by the carriage, and wherein thecarriage mount is configured to move along in a direction of alongitudinal axis of the mandrel.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages will be apparent from the description anddrawings, and from the claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a conceptual diagram illustrating an example of a therapysystem that delivers electrical stimulation therapy to a patient.

FIG. 2A is a conceptual block diagram of an example of a medical devicesystem.

FIG. 2B is a conceptual block diagram of an example of an assemblysystem.

FIG. 3 is a functional block diagram illustrating components of animplantable medical device.

FIGS. 4A-4F are conceptual diagrams illustrating an example componentsof a modular medical lead.

FIGS. 5A-5U illustrate examples of portions of a modular medical leadsystem.

FIGS. 6A-6R illustrate examples of portions of an assembly system.

FIGS. 7A-7K illustrate examples of a modular medical lead system and anassembly system therefor.

FIGS. 8A-H illustrate examples of a modular medical lead system.

FIGS. 9A-C illustrate examples of an assembly system.

FIGS. 10A-B illustrate examples of a method for assembling a modularmedical lead system.

FIGS. 11A-11I illustrate examples of a modular medical lead system.

FIGS. 12A-H illustrate examples of a conductor hub.

DETAILED DESCRIPTION

As described above, some examples of the disclosure relate to medicaldevice leads (also referred to as “lead systems,” “medical leads,” or“leads”) including one or more electrodes. Using the lead and electrode,a medical device may deliver or sense electrical signals to providetherapy to a patient to treat a patient condition. Medical leads mayinclude a conductive electrode member electrically and mechanicallyconnected to one or more conductive lead wires (also may be referred toas “conductors”) extending through the lead body. Electrical stimulationfrom a medical device may be conductive along the lead wire to bedelivered across the electrode surface.

In some examples, a medical device system includes a medical device,such as an ambulatory medical device (AMD) or an implantable medicaldevice (IMD). The medical device system may include lead system, such asa modular medical lead system. In an example, the modular medical leadsystem includes an elongate lead body module, which may include asection having conductors in a coiled arrangement and one or moreconductor hubs. In some examples, the elongate lead body module includesone or more conductor hubs, such as in the finished product to beimplanted in a patient. The conductor hub may be used as a starting hubor a conductor distribution hub during the manufacture of the leadsystem. In some examples, the conductor hub may be used for starting themanufacture of the elongate lead body module, and in other examples maybe used for finishing the manufacture of the elongate lead body module,such as once the conductors are in a coiled arrangement or anotherarrangement along a length of the elongate lead body module. In someexamples, an arrangement of the conductors may not be maintained withoutthe help of a device or other assistance. In one example, the conductorhub helps to maintain the arrangement of the conductors during and aftermanufacture of the elongate lead body module.

The modular medical lead system may include one or more lead endmodules. In one example, the lead end module is an electrode module withan electrode arrangement configured to treat the patient condition or tosense the electrical signal. In another example, the lead end module isa connector module, such as may be configured to connect to the medicaldevice. The connector module may have a plurality of electricalcontacts, such as corresponding to the plurality of conductors in theelongate lead body module, where the electrical contacts couple torespective contacts of the medical device or a conductor (lead)extension which in turn coupled to a medical device. In some examples,the modular medical lead system includes a jacket module. The jacketmodule may be electrically insulated or biocompatible. The jacket modulemay cover the conductor hub. In some examples, the jacket module is overmolded on the coiled arrangement of conductors.

The modular medical lead system may comprise two or more modules. In oneexample, the modular medical lead system includes the electrode modulecoupled to the elongate lead body module on a first end of the elongatelead body module, and the connector module coupled to a second end ofthe elongate lead body module. In another example, a lead body modulemay be coupled to an electrode module at a first end and the second endof the lead body module may include electrical contacts configured tocouple the lead body module to the electronics of an IMD or othermedical device, e.g., as opposed to a separate connector module beingjoined to the lead body module. In another example, a lead body modulemay be coupled to a contact module at a first end and the second end ofthe lead body module may include one or more electrodes configured todeliver electrical stimulation and/or sense electrical signals, e.g., asopposed to a separate electrode module being joined to the lead bodymodule. In another example, the modular medical lead system includes twoor more elongate lead body modules coupled directly to each other. In anexample, a first elongate lead body module is coupled to the electrodemodule on a first end of the electrode module, and a second elongatelead body module is coupled to the electrode module on a second end ofthe electrode module. Other types of modules may be used in the modularmedical lead system, such as may include a conductor extension modulethat may provide additional length to the lead, a sensor module that maybe configured to sense a particular physiological parameter, a deliverymodule that may be configured to provide a therapeutic effect other thanelectrical stimulation, such as physically or mechanically. Other typesof modules may be used for various purposes, and the modular medicallead system may include combinations or one or more types of modules.

Some aspects of the disclosure relate to a process including winding oneor more conductors for the elongate lead body module to form a coiledarrangement of conductors between a first end and a second end of theelongate lead body module. The one or more conductors may beelectrically conductive wires for use in the medical device system. Insome examples, the conductors are electrically insulated from oneanother, such as may include using an insulated layer or coating. Insome examples, the conductor may include a single strand, such as a“filar,” a “wire,” or another single strand that is electricallyconductive. In other examples, the conductor may comprise a coil. Thecoil may include multiple conductive strands coiled or wound together,as by a mandrel. The one or more coiled conductors may have a diametersmaller than the overall coiled arrangement, such that the coiledarrangement of the elongate lead body module may comprise one or moresmaller coils. In other examples, the conductor may refer to a cable.The cable may include multiple conductive wires, filars, otherconductors, or a combination thereof, twisted, wrapped, or otherwisegrouped together, such as to form a conductor. In some examples, a cablemay include a bundle of strands of wire, such as may be referred to as a“BSW.” In some examples, a coiled structure that is formed of the one ormore cables may be referred to as a “coible.”

In an example, a portion of the ends of individual conductors may extendbeyond a conductor hub. The portion of the conductor that extends beyondthe conductor hub may be used to couple the elongate lead body module toa lead end module. For example, the portion may be coupled to the leadend module. In another example, the portion may be coupled to arespective portion of a conductor extending from the lead end module. Insome examples, coupling multiple modules includes welding, such as laserwelding. Any other type of mechanism for coupling these modules may beused in addition to, or instead of, welding including, withoutlimitation, conductive glue, crimping, or swaging. As such, the portionmay be welded to the lead end module itself, or to the respectiveportion of the conductor extending from the lead end module.

In some examples, the elongate lead body module includes an arrangementof conductors between the first and the second ends of the elongate leadbody module. In an example, the arrangement is a coiled arrangement,such that multiple conductors are wound around a longitudinal axis ofthe elongate lead body module. In another example, the arrangementincludes a straight arrangement, such that one or more conductors aresubstantially straight relative to the longitudinal axis of the elongatelead body module. The conductors may be coupled to the conductor hub.And, in some examples, the conductors form a straight arrangement withinchannels of the conductor hub. In some examples, the portion of theconductor that extends beyond the conductor hub is in a straightarrangement, such as may be used to couple the elongate lead body moduleto another module.

As described herein, the conductors may be in the coiled arrangement upto the conductor hub, and then past the conductor hub, the portion ofthe conductors such as extending out of the channels of the conductorhub may be in the straight arrangement. In this way, the elongate leadbody module may include a “coiled to straight” arrangement of theconductors. In another example, the plurality of conductors of theelongate lead body module includes a “straight to coiled to straight”arrangement. In some examples, the portion of the conductors extendingout of the channels are in an angled arrangement, such as relative tothe longitudinal axis of the elongate lead body module. In someexamples, the portion of the conductors extending out of the channelsare in a helical or coiled arrangement. In some examples, the portion ofthe conductors extending out of the channels define a diameter largerthan a diameter of the coiled arrangement of the elongate lead bodymodule. And in other examples, the portion of the conductors extendingout of the channels define a diameter smaller than the diameter of thecoiled arrangement of the elongate lead body module. The arrangement ofthe plurality of conductors at the first and second ends of the elongatelead body module may be sized or shaped to a desired arrangement, suchas for coupling to another module.

The modular medical lead system may be manufactured using an assemblysystem. In some examples, the assembly system includes an assemblyapparatus and a winder apparatus. The assembly apparatus may include abase, and a carriage may be placed on the base. In some examples, thecarriage includes a plurality of bobbins. A plurality of conductors maybe wound around the respective plurality of bobbins, such that eachconductor may correspond to a particular bobbin. The bobbins may becoupled to the carriage, such as by being placed on a pin of thecarriage. The carriage may comprise a circular shape, and the bobbinsmay be distributed in a circular shape including, for example, a smallerdiameter than a diameter of the carriage. Using the assembly apparatus,for example, the conductors may be coupled to the conductor hub. In oneexample, each of the plurality of conductors is threaded into arespective channel of the conductor hub. In an example, the plurality ofconductors are coupled to the respective plurality of channels of theconductor hub automatically, such as by using a robotic arm or aCartesian gantry robotic arm, and computer vision.

In some examples, the winder apparatus includes a mandrel extending froma first section to a second section of the winder apparatus. The winderapparatus may include a motor coupled to the mandrel in the firstsection. The winder apparatus may include a carriage mount configured tocouple to the carriage. The mandrel may extend through an openingdefined by the carriage. The carriage mount may be configured to movealong in a direction of a longitudinal axis of the mandrel.

In an example, when the carriage is coupled to the carriage mount on thewinder apparatus, the conductor hub may be coupled to the mandrel suchthat when the motor is activated, the mandrel and the conductor hubrotate together. In an example, the coiled arrangement of the conductorsof the elongate lead body module is formed by rotating the mandrel whilethe carriage mount moves away from the conductor hub, along a length ofthe mandrel. As such, the conductors may unwind from the bobbins as theconductors are wound around the mandrel, and a plurality ofcorresponding brakes coupled to the bobbins may control the angularspeed of the bobbins, or the tensions of the conductors or the torque ofthe conductors.

In an example, modular lead construction may include discrete lead endmodules that are connectable to an elongate lead body module. Modulararchitecture may provide agile product development and may improvemanufacturability while increasing the features and performance knownwith legacy or conventional architectures. By using the modular medicallead system, such as described in this disclosure, a joint may be formedwhere two modules are connected, such as by including a desiredpresentation of conductors at one or more ends of the elongate lead bodymodule, such as by using the conductor hub. The features describedherein may be used with leads having diameters under 0.060 inches, forexample. In some examples, the diameters may be 0.050 inches or less. Inone example, such as for a lead including 16 conductors, a diameter maybe about 0.060 inches or more. In other examples, medical devicesmanufactured using features described herein may have much largerdiameters extending to 0.5 inches or more, such as when used inscreening or diagnostic cable applications that are not intended forimplantation. In some examples the construction of the medical leadsystem may not depend on operator skill.

In one example, the subject matter herein includes a modular lead systemincluding eight or more conductors, and including a diameter of about0.060 inches or less. The diameter will scale as more conductors areincluded in the system. For instance, a system having thirty or moreconductors (e.g., thirty-two conductors) may have a diameter of 0.150inches or greater. A conductor hub may be used as a starting hub tolocate and fix the conductors into a desired presentation orarrangement. A method may include using with discrete lengths ofconductors (e.g., conductive wires), such as may be preterminated asneeded, on bobbins to facilitate lead assembly. The bobbins and thestarting hub may be set-up on an assembly carriage. In an example, thecarriage may be transferred to a wire insertion station (such as awinder apparatus) that utilizes mechanized fixtures or robotics toinsert the wires into the guides. The carriage may then be transferredto a winding machine where the guide is driven to create the coiledarrangement of the elongate lead body module. A coil-to-straight wirepresentation may be provided using the features and techniques herein.In an example, the other end can also be terminated with a guide (e.g.,a second conductor hub) using similar fixtures insert the conductors andcreate wire termination presentations to connect both distal andproximal lead end modules. In some examples, one or more conductor hubsmay be formed on the lead body during the winding process (e.g., whilecoiling conductors on the unfinished elongate lead body module on thewinding apparatus). For example, a sleeve, such as a polyurethanesleeve, may be positioned over an area of the elongate lead body modulewhere a hub is desired, and the sleeve may be heated, resulting in amolded hub (e.g., using a reflow process).

In an example the manufacturing process may include termination ofconductors for a coil, such as may be located and controlled in adesired presentation before the winding of the coil begins. In someexamples interfacing the yet-to-be-formed elongate lead body module witha winder apparatus is provided. In one example, coupling two modules ina side-by-side or over-under presentation for a weld joint is describedherein.

As will be apparent from the disclosure, examples of the disclosure mayprovide one or more advantages. In some examples, by manufacturing amodule lead according to some examples described herein, manufacturingcosts for a lead may be reduced, or manufacturing efficiency or yieldmay be increased. In an example, the elongate lead body module may firstbe manufactured without electrodes and/or connectors for connection toan IMD. Subsequently, the lead body module may be coupled to one or morelead end modules, such as, e.g., an electrode module having a desiredarrangement of electrodes selected from several different electrodesmodules and/or a connector module have a desired arrangement ofconnectors selected from several different connector modules.Alternatively, the elongate lead body module may be used to form a leadextension, with a distal end being coupled to a connector for connectionto a proximal end of a lead module, and a proximal end being coupled toa connector for connection to an IMD. As another example, the bodymodule may be coupled to any other type of end modules to manufacture amodular device having an elongate body with one or more conductors thathave one or more ends that transition into a fixed format, with each endcoupling to a respective end module. In some cases, the resultingmedical system may be a monitoring device intended for acute monitoringor diagnostic purposes rather than for chronic implantation in the body.In other cases, the system may comprise a screening device that deliverstherapy acutely to determine efficacy (e.g., as priority implantation).Thus, methods, devices, structures, and system described herein mayrelate to any type of acute or chronic medical devices, includingmedical electrical or other leads, lead extensions, trialing devices,screening systems, diagnostic devices, monitoring devices, or any othersystems comprising elongate bodies with one or more conductors thattransition at one or more ends to predetermined configurations forattachment in a module manner to end modules. In some examples, thesetechniques may be applied to non-medical applications, such asmanufacturing cables for the various purposes for electronics industry.

In this manner, each elongate body module may be coupled to any numberof differently configured end connector modules and/or electrodemodules, as compared to a non-modular lead in which the end connectorand electrode configuration at the ends of the lead body. In someexamples, the conductor hub of a lead body module may fix thearrangement of the conductors end in a manner that matches thearrangement of conductors of an electrode module and/or connectormodule. In this manner, the conductors of the lead body module may bedirectly joined to the corresponding conductors of the electrode moduleand/or connector module, e.g., with the use of a separate interconnectormember.

In an example, the techniques to manufacture the modular medical leadsystem described in this disclosure may increase the reliability of themanufacturing process, such as may include providing more uniform endproducts. In an example, the features and techniques described in thisdisclosure may reduce the need to dispose of a non-usable portion of acoiled arrangement of a lead made using conventional techniques. In anexample, by using the modular medical lead system described herein, adesired number of individual conductors may be used, such as, e.g., fromeight to sixteen conductors, from two to four conductors, or fromthirty-two to forty conductors. In other examples, even more conductorsmay be used, e.g., thirty-two or more conductors. In some examples, thetechniques described in this disclosure may provide the ability tomanufacture elongate lead body modules of a desired length, which may besubsequently joined with a connector module and/or electrode module asdesired. In some examples, the elongate lead body module may include acoiled to straight arrangement for the conductors, where the conductorsare in a coiled arrangement directly past one end of the conductor huband in a straight arrangement past a second end of the conductor hub.The conductor hub may allow for a relatively short transition lengthform the coiled to straight arrangement of the conductors.

In some examples, modules of the modular architecture may be utilizedwith a variety of different lead designs (e.g., electrode modules and/orconnector modules) without the need to repeat the regulatory processneeded for approval of an entire non-modular lead assembly. This mayallow quicker and less costly development cycles.

In some examples, the modular architecture may provide ease ofmanufacturability and lowering cost of goods. For example, thetechniques and features herein may not rely on the skill of a humanoperator, e.g., in coiling or other manufacturing a medical lead byhand.

Quality, precision, consistency, and manufacturing efficiency may beobtained by use of automated or mechanized assembly rather than a humanoperator, or other features and techniques described herein.

FIG. 1 is a conceptual diagram illustrating an exemplary therapy system10 including modular lead 50 implanted in the brain 49 of patient 40.For ease of illustration, examples of the disclosure will primarily bedescribed with regard to implantable electrical stimulation leads andimplantable medical devices that neurostimulation therapy to a patient'sbrain in the form of deep brain stimulation (DBS). However, the featuresand techniques described herein may be useful in other types of medicaldevice systems which employ medical leads to deliver electricalsstimulation to a patient and/or sense electrical signals via one or moreelectrodes of the lead. For example, the features and techniquesdescribed herein may be used in systems with medical devices thatdeliver stimulation therapy to a patient's heart, e.g., pacemakers, andpacemaker-cardioverter-defibrillators. As other examples, the featuresand techniques described herein may be embodied in systems that deliverother types of neurostimulation therapy (e.g., spinal cord stimulationor vagal stimulation), stimulation of at least one muscle or musclegroups, stimulation of at least one organ such as gastric systemstimulation, stimulation concomitant to gene therapy, and, in general,stimulation of any tissue of a patient. The modular medical lead systemmay be used with human subjects or with non-human subjects.

As shown in FIG. 1, therapy system 10 includes medical device programmer22, IMD 20, and modular lead 50. Modular lead 50 includes plurality ofelectrodes 116. IMD 20 includes a stimulation therapy module thatincludes an electrical stimulation generator that generates and deliverselectrical stimulation therapy to one or more regions of brain 49 ofpatient 40 via one or more of electrodes 116. In the example shown inFIG. 1, therapy system 10 may be referred to as a DBS system because IMD20 provides electrical stimulation therapy directly to tissue withinbrain 49, e.g., a tissue site under the dura mater of brain 49. In otherexamples, leads 50 may be positioned to deliver therapy to a surface ofbrain 49 (e.g., the cortical surface of brain 49).

In accordance with examples of the disclosure, modular lead 50 includesconnector module 59, lead body module 52, and electrode module 57.Connector module 59 is coupled to one end of lead body module 52 atjoint 61 and electrode module 57 is coupled to the other end of the leadbody module at joint 63. As modular lead 50 is assembled, respectiveelectrical connectors of connector module provide an electricalconnection between IMD 20 and the conductive pathways of modular leadrunning to electrodes 16 of electrode module 57 defined by the pluralityof conductors of lead body module 52. Using the conductive pathways, IMD20 may deliver electrical stimulation to patient 40 and/or senseelectric signals of patient 40 using modular lead 50.

In the example shown in FIG. 1, IMD 20 may be implanted within asubcutaneous pocket above the clavicle of patient 40. In other examples,IMD 20 may be implanted within other regions of patient 40, such as asubcutaneous pocket in the abdomen or buttocks of patient 40 orproximate the cranium of patient 40. Connector module 59 of modular lead50 is coupled to IMD 20 via a connector block (also referred to as aheader), which may include, for example, electrical contacts thatelectrically couple to respective electrical contacts on connectormodule 59 of lead 50. The electrical contacts electrically couple theelectrodes 116 carried by electrode module 57 of lead 50. Lead 50traverses from the implant site of IMD 20 within a chest cavity ofpatient 40, along the neck of patient 40 and through the cranium ofpatient 40 to access brain 49. Generally, IMD 20 is constructed of abiocompatible material that resists corrosion and degradation frombodily fluids. IMD 20 may comprise a hermetic housing to substantiallyenclose components, such as a processor, therapy module, and memory.

Lead 50 may be positioned to deliver electrical stimulation to one ormore target tissue sites within brain 49 to manage patient symptomsassociated with a disorder of patient 40. Lead 50 may be implanted toposition electrodes 116 at desired locations of brain 49 throughrespective holes in cranium 48. Lead 50 may be placed at any locationwithin brain 49 such that electrodes 116 are capable of providingelectrical stimulation to target tissue sites within brain 49 duringtreatment. Although FIG. 1 illustrates system 10 as including a singlelead 50 coupled to IMD 20, in some examples, system 10 may include morethan one lead.

Lead 50 may deliver electrical stimulation via electrodes 116 to treatany number of neurological disorders or diseases in addition to movementdisorders, such as seizure disorders or psychiatric disorders. Lead 50may be implanted within a desired location of brain 49 via any suitabletechnique, such as through respective burr holes in a skull of patient12 or through a common burr hole in the cranium 48. Lead 50 may beplaced at any location within brain 49 such that electrodes 116 of lead50 are capable of providing electrical stimulation to targeted tissueduring treatment. In the examples shown in FIG. 1, electrodes 116 oflead 50 are shown as segmented electrodes. In other examples, electrodes116 of lead 50 may have different configurations including ring orpaddle electrodes. Electrodes 116 of lead 50 may have a complexelectrode array geometry that is capable of producing shaped electricalfields. In this manner, electrical stimulation may be directed to aspecific direction from lead 50 to enhance therapy efficacy and reducepossible adverse side effects from stimulating a large volume of tissue.

IMD 20 may deliver electrical stimulation therapy to brain 49 of patient40 according to one or more stimulation therapy programs. A therapyprogram may define one or more electrical stimulation parameter valuesfor therapy generated and delivered from IMD 20 to brain 49 of patient40. Where IMD 20 delivers electrical stimulation in the form ofelectrical pulses, for example, the stimulation therapy may becharacterized by selected pulse parameters, such as pulse amplitude,pulse rate, and pulse width. In addition, if different electrodes areavailable for delivery of stimulation, the therapy may be furthercharacterized by different electrode combinations, which can includeselected electrodes and their respective polarities. The exact therapyparameter values of the stimulation therapy that helps manage or treat apatient disorder may be specific for the particular target stimulationsite (e.g., the region of the brain) involved as well as the particularpatient and patient condition.

In addition to delivering therapy to manage a disorder of patient 40,therapy system 10 monitors electrical signals, such as, e.g., one ormore bioelectrical brain signals of patient 40. For example, IMD 20 mayinclude a sensing module that senses bioelectrical brain signals withinone or more regions of brain 49. In the example shown in FIG. 1, thesignals generated by electrodes 116 are conducted to the sensing modulewithin IMD 20 via conductors within lead 50, including one or moreconductors within lead body module 52 between electrode module 57 andconnector module 59.

External programmer 22 wirelessly communicates with IMD 20 as needed toprovide or retrieve therapy information. Programmer 22 is an externalcomputing device that the user, e.g., the clinician and/or patient 40,may use to communicate with IMD 20. For example, programmer 22 may be aclinician programmer that the clinician uses to communicate with IMD 20and program one or more therapy programs for IMD 20.

Alternatively, programmer 22 may be a patient programmer that allowspatient 40 to select programs and/or view and modify therapy parameters.The clinician programmer may include more programming features than thepatient programmer. In other words, more complex or sensitive tasks mayonly be allowed by the clinician programmer to prevent an untrainedpatient from making undesired changes to IMD 20.

Programmer 22 may be a hand-held computing device with a displayviewable by the user and an interface for providing input to programmer22 (i.e., a user input mechanism). In other examples, programmer 22 maybe a larger workstation or a separate application within anothermulti-function device, rather than a dedicated computing device. Forexample, the multi-function device may be a notebook computer, tabletcomputer, workstation, cellular phone, personal digital assistant, oranother computing device that may run an application that enables thecomputing device to operate as a secure medical device programmer 22.

As noted above, lead 50 may include electrode module 57 including acomplex electrode array geometry, but may also include one or moresingle ring electrodes along the longitudinal axis in other examples. Inone example, electrode module 57 includes a plurality of electrodespositioned at different axial positions along the longitudinal axis ofthe lead and a plurality of electrodes positioned at different angularpositions around the circumference of the lead (which may be referred toas electrode segments). In this manner, electrodes may be selected alongthe longitudinal axis of lead 50 and along the circumference of thelead. Selectively activating electrodes of lead 50 can producecustomizable stimulation fields that may be directed to a particularside of lead 50 in order to isolate the stimulation field around thetarget anatomical region of brain 49.

Again, while lead 50 is described here for use in DBS applications, lead50 or other leads may be implanted at any other location within patient40. For example, lead 50 may be implanted near the spinal cord, pudendalnerve, sacral nerve, or any other nervous or muscle tissue that may bestimulated. The user interface described herein may be used to programthe stimulation parameters of any type of stimulation therapy. In thecase of pelvic nerves, defining a stimulation field may allow theclinician to stimulate multiple desired nerves without placing multipleleads deep into patient 40 and adjacent to sensitive nerve tissue.Therapy may also be changed if leads migrate to new locations within thetissue or patient 40 no longer perceives therapeutic effects of thestimulation. The features or techniques of this disclosure may be usefulin other types of medical applications.

FIG. 3 is a functional block diagram illustrating components of IMD 20.As shown, medical device system 10 includes IMD 20 coupled to modularmedical lead system 50. In the example of FIG. 3, IMD 20 includesprocessor circuitry 24 (also referred to as “processor”), memory 26,stimulation generator 21, sensing module 60, telemetry module 23, sensor25, and power source 29. Each of these components (also referred to as“modules” may be or include electrical circuitry configured to performthe functions attributed to each respective module). For example,processor 24 may include processing circuitry, stimulation generator 21may include switch circuitry, sensing module 60 may include sensingcircuitry that may be electrically coupled to electrodes 116 to allowfor sensing of, e.g., bioelectrical signals of the patient such asbioelectrical brain signals, and telemetry module 23 may includetelemetry circuitry. Memory 26 may include any volatile or non-volatilemedia, such as a random access memory (RAM), read only memory (ROM),non-volatile RAM (NVRAM), electrically erasable programmable ROM(EEPROM), flash memory, and the like. Memory 26 may storecomputer-readable instructions that, when executed by processor 24,cause IMD 20 to perform various functions. Memory 26 may be a storagedevice or other non-transitory medium.

In the example shown in FIG. 3, memory 26 stores therapy programs 27 andsense electrode combinations and associated stimulation electrodecombinations 28 in separate memories within memory 26 or separate areaswithin memory 26. Each stored therapy program 27 defines a particularset of electrical stimulation parameters (e.g., a therapy parameterset), such as a stimulation electrode combination, electrode polarity,current or voltage amplitude, pulse width, and pulse rate. In someexamples, individual therapy programs may be stored as a therapy group,which defines a set of therapy programs with which stimulation may begenerated. The stimulation signals defined by the therapy programs ofthe therapy group include stimulation pulses that may be deliveredtogether on an overlapping or non-overlapping (e.g., time-interleaved)basis. Stimulation signals may be of any form, such as pulses,continuous-time signals (e.g., sine waves) or the like.

Processor 24 may include any one or more of a microprocessor, acontroller, a digital signal processor (DSP), an application specificintegrated circuit (ASIC), a field-programmable gate array (FPGA),discrete logic circuitry, or any other processing circuitry configuredto provide the functions attributed to processor 24 herein may beembodied as firmware, hardware, software or any combination thereof.Processor 24 controls stimulation generator 21 according to therapyprograms 27 stored in memory 26 to apply particular stimulationparameter values specified by one or more of programs, such asamplitude, pulse width, and pulse rate.

In the example shown in FIG. 3, modular medical lead system 50 includesone or more electrodes 116 located on electrode module 57. Processor 24also controls stimulation generator 21 to generate and apply thestimulation signals to selected combinations of electrodes of theelectrode module. In some examples, stimulation generator 21 includes aswitch module that couples stimulation signals to selected conductorswithin lead 50, which, in turn, delivers the stimulation signals acrossselected electrodes. Such a switch module may be a switch array, switchmatrix, multiplexer, or any other type of switching module configured toselectively couple stimulation energy to selected electrodes and toselectively sense bioelectrical neural signals of the spine withselected electrodes.

In other examples, however, stimulation generator 21 does not include aswitch module. In these examples, stimulation generator 21 comprises aplurality of pairs of voltage sources, current sources, voltage sinks,or current sinks connected to each of electrodes such that each pair ofelectrodes has a unique signal generator. In other words, in theseexamples, each of electrodes is independently controlled via its ownsignal generator (e.g., via a combination of a regulated voltage sourceand sink or regulated current source and sink), as opposed to switchingsignals between electrodes.

Stimulation generator 21 may be a single channel or multi-channelstimulation generator. In particular, stimulation generator 21 may becapable of delivering a single stimulation pulse or multiple stimulationpulses at a given time via a single electrode combination or multiplestimulation pulses at a given time via multiple electrode combinations.In some examples, however, stimulation generator 21 may be configured todeliver multiple channels on a time-interleaved basis. For example, aswitch module of stimulation generator 21 may serve to time divide theoutput of stimulation generator 21 across different electrodecombinations at different times to deliver multiple programs or channelsof stimulation energy to patient 40. In another example, the stimulationgenerator 21 may control the independent sources or sinks on atime-interleaved bases.

Electrodes 116 of electrode module 57 of modular lead 50 may beconstructed of a variety of different designs. For example, one or moreleads 50 may include two or more electrodes at each longitudinallocation along the length of the lead, such as multiple electrodes atdifferent perimeter locations around the perimeter of the lead at eachof the locations, such as by using electrode modules. In one example,the electrodes may be electrically coupled to the switch module viarespective conductors that are straight or coiled within the housing thelead, such as in elongate lead body module 52, and run to connectormodule 59 at the proximal end of the modular lead 50.

Although sensing module 60 is incorporated into a common housing withstimulation generator 21 and processor 24 in FIG. 3, in other examples,sensing module 60 may be in a separate housing from IMD 20 and maycommunicate with processor 24 via wired or wireless communicationtechniques. Example bioelectrical signals include, but are not limitedto, a signal generated from local field potentials within one or moreregions of the brain, for example.

Sensor 25 may include one or more sensing elements that sense values ofa respective patient parameter. For example, sensor 25 may include oneor more accelerometers, optical sensors, chemical sensors, temperaturesensors, pressure sensors, or any other types of sensors. Sensor 25 mayoutput patient parameter values that may be used as feedback to controldelivery of therapy. IMD 20 may include additional sensors within thehousing of IMD 20 and/or coupled as a separate module via one of lead 50or other leads. In addition, IMD 20 may receive sensor signalswirelessly from remote sensors via telemetry module 23, for example. Insome examples, one or more of these remote sensors may be external topatient (e.g., carried on the external surface of the skin, attached toclothing, or otherwise positioned external to the patient).

Telemetry module 23 supports wireless communication between IMD 20 andan external programmer (e.g., such as programmer device 22) or anothercomputing device under the control of processor 24. Processor 24 of IMD20 may receive, as updates to programs, values for various stimulationparameters such as amplitude and electrode combination, from programmer22 via telemetry module 23. The updates to the therapy programs may bestored within therapy programs 27 portion of memory 26. Telemetry module23 in IMD 20, as well as telemetry modules in other devices and systemsdescribed herein, such as programmer 22, may accomplish communication byradiofrequency (RF) communication techniques. In addition, telemetrymodule 23 may communicate with external medical device programmer 22 viaproximal inductive interaction of IMD 20 with programmer 22.Accordingly, telemetry module 23 may send information to externalprogrammer 22 on a continuous basis, at periodic intervals, or uponrequest from IMD 20 or programmer 22.

Power source 29 delivers operating power to various components of IMD20. Power source 29 may include a small rechargeable or non-rechargeablebattery and a power generation circuit to produce the operating power.Recharging may be accomplished through proximal inductive interactionbetween an external charger and an inductive charging coil within IMD20. In some examples, power requirements may be small enough to allowIMD 20 to utilize patient motion and implement a kineticenergy-scavenging device to trickle charge a rechargeable battery. Inother examples, traditional batteries may be used for a limited periodof time.

FIG. 2A is a block diagram of medical device system 10. Medical devicesystem 10 may include medical device 20. Medical device system 10 mayinclude modular medical lead system 50. In some examples, modularmedical lead system 50 includes two or more modules to form a medicallead. As described herein, a medical device may deliver electricalstimulation therapy to patient 40 and/or to sense an electrical signalof patient 40 using the medical lead. Modular medical lead system 50 mayprovide flexibility in manufacturing medical leads, such as byleveraging economies of scale in making modules, rather than making anon-modular lead system.

Modular medical lead system 50 may include one or more lead end modules56. In one example, lead end module 56 is an electrode module configuredto be placed at a target site within patient 40. As another example,lead end module 56 may be a connector module configured to couple themodular medical lead system 50 to corresponding electrical connectors ofmedical device 20. Other example types of lead end modules may be used.

Modular medical lead system 50 also includes an elongate lead bodymodule 52. In some examples, elongate lead body module 52 includes aplurality of conductors electrically isolated from one another to formseparate channels, circuits, or conductive paths through the lead bodyalthough techniques described herein also apply to a body modulecarrying one a single conductor. In some example the plurality ofconductors includes eight to sixteen conductors although other numbersof conductors are contemplated, including more than sixteen (e.g., 32 ormore). In one example, lead body module 52 includes nine conductors.Elongate lead body module 52 may include conductors in a coiledarrangement. The coiled arrangement of conductors may by wound around alongitudinal axis of elongate lead body module, such as when elongatelead body module is placed on a table and is in a straight position.

In some examples, the coiled arrangement has a diameter of about 0.25millimeters to about 10 millimeters, such as, e.g., about 0.7millimeters to about 1.5 millimeters, although other values arecontemplated. For instance, the diameter may scale based on the numberof conductors and may depend on the application of use. For applicationsthat are non-implantable, such as for use with trialing or monitoringcables that will remain outside a patient's body, the diameters may be0.50 inches or more. The coiled arrangement of conductors may be made bywinding the plurality of conductors around a mandrel, such as describedin this disclosure. In some examples, elongate lead body module includesa conductor hub. In other examples, the elongate lead body moduleincludes one or more conductor hubs, such as a first conductor hubpositioned near a first end of elongate lead body module 52 and a secondconductor hub positioned near a second end of elongate lead body module52.

Modular medical lead system 50 may include a jacket module 54. Jacketmodule 54 may be coupled to all or part of other modules of modularmedical lead system 50. For example, jacket module 54 may be positionedon the entire elongate lead body module 52 and also on a portion of oneor more lead end module 56, such as to insulate portions of the modulesfrom patient (e.g., patient 40). In some examples, jacket module 54covers a partial portion of elongate lead body module 52. In someexamples, multiple jacket modules may be positioned or otherwise coupledto other modules of modular medical lead system 50. Jacket module 54 maybe shielded for magnetic resonance imaging. Jacket module 54 maycomprise a biocompatible material. Jacket module 54 may comprise amechanically resilient material. When jacket module 54 surroundselongate lead body module 52, the modules together may have a totaldiameter of about 1 millimeter to about 12 millimeters, such as, e.g.,about 1 millimeter to about 1.6 millimeters, although other values arecontemplated.

The one or more conductor hubs of elongate lead body module 52 may beused as a starting hub in manufacturing modular elongate lead bodymodule 52. The one or more conductor hubs of elongate lead body module52 may be used as wire distribution hub in manufacturing modularelongate lead body module 52. The conductor hub may include a pluralityof channels, where the number of channels correspond to the number ofconductors being used in elongate lead body module 52. In an examplewhere lead body module 52 includes only a single conductor, conductorhub may include only a single channel. The conductors may generally bein the coiled configuration on one side of the conductor hub, and maygenerally be in a straight configuration on the other side of theconductor hub.

Elongate lead body module 52 may be sized and shaped to allow a styletto pass through an inner lumen defined by the coiled electrodes. Assuch, in an example, the connector module includes a stylet passfeature. The conductor hub may be sized to fit within jacket module 54.In some examples, where elongate lead body module 52 includes the firstconductor hub and the second conductor hub, only one of the twoconductor hubs is sized to fit within jacket module 54, such that theother of the two conductor hubs is larger (e.g., has a larger diameter).Yet, in other examples, each of the two conductor hubs are sized andshaped to fit within jacket module 54.

As will be described further below, the conductor hub may include adrive feature. The conductor hub may define an opening, such as may formthe drive feature. In an example, the drive feature is an openingconfigured to couple to a component of a winder apparatus or an assemblyapparatus. For example, the drive feature may be configured to couple toa motor of the winder apparatus, whether directly or indirectly. Assuch, a component of the winder apparatus may couple to the conductorhub, such as by being disposed inside the drive feature. In otherexamples, the conductor hub includes an external drive features, suchthat a component of the winder apparatus may couple to the outside ofthe conductor hub (e.g., such as by using ridges or grooves to form amechanical connection).

The conductors of elongate lead body module 52 may extend from a firstend to a second end of elongate lead body module 52. In an example, aportion of one or more of the plurality of conductors extends past theconductor hub. In an example, the portion is an ablated insulation end.For example, the portion is ablated such that the electrically insulatedlayer of the conductor is stripped away, such as for coupling to othermodules. This may include a welded coupling, such as to the lead endmodule.

FIG. 2B is a conceptual block diagram of an example of an assemblysystem 100. Assembly system 100 may include an assembly apparatus 100.Assembly system 100 may include a winder apparatus 120. In someexamples, these apparatuses may be positioned at a single station (e.g.,a work station or a manufacturing station). In some examples, theseapparatuses may be positioned at separate stations (e.g., two differentstations). Yet in other examples, assembly system 100 comprises acombined assembly/winder apparatus. Assembly system 100 may includeautomated portions, such as by using robotic arms, mechanized fixtures,automated computer systems, or the like. Example operation of assemblysystem 100, e.g., to form an elongate lead body module, is describedfurther below.

FIG. 4A is a conceptual diagram illustrating an example of modularmedical lead 50. Modular lead 50 may include elongate lead body module52, electrode module 57, and connector module 59 joined with each. Inthe example of FIG. 4A, elongate lead body module 52 includes twoconductor hubs 270A and 270B. In this example, there are nine conductorscorresponding to nine electrodes and nine electrical contacts, such thatthe modular lead 50 defines nine isolated electrical paths or channelsfor delivery of therapy and/or sensing of electrical signals. Forexample, electrodes 201-206 are illustrated on electrode module 57(electrodes 207-209 not shown). In this example, there are three sets ofthree electrodes on the electrode module, such that each set is alignedalong a longitudinal axis of the electrode module and the sets areplaced circumferentially around outer surface of electrode module 57.Likewise, for example, electrical contacts 221-229 are positioned alongconnector module 59. Conductors 251-259 may be in a coiled arrangement,such as may be seen in elongate lead body module 52 of FIG. 4A. In thisexample, conductor 251 interconnects electrode 201 and electricalcontact 221. As such, conductor 252 interconnects electrode 202 andelectrical contact 222, and so on for the plurality of conductors.

FIG. 4D is a conceptual diagram of the example elongate lead body module52 shown in FIG. 4A prior to be joined to electrode module 57 andconnector module 59, and without jacket module 54. As shown, eachconductor of plurality of conductors 251-259 extends from first end 27Ato second end 271B of first conductor hub 270A relative to alongitudinal axis 525 of elongate lead body module 52 such that aportion 524A of conductors 251-259 extends beyond first end 271A offirst conductor hub 270A. In some examples for each conductor ofconductors 251-259, the portion 524A that extends beyond first end 271Aof first conductor hub 270A is coupled (not shown in FIG. 4D) to arespective electrical conductor of a lead end module (e.g., such aselectrode module 57 as in the examples of FIG. 4A), to allow respectiveelectrical signals to be conducted between the respective conductors ofthe lead end module and the conductors 251-259 of elongate lead bodymodule 52. Elongate lead body module 52 also includes second conductorhub 270B. Plurality of conductors 251-259 are electrically isolated fromone another and mechanically coupled to second conductor hub 270B suchthat conductors 251-259 are in a fixed arrangement relative to oneanother (such as may be seen at second end 522). In some examples asecond end 272B of second conductor hub 270B is nearer second end 522 ofelongate lead body module 52 than a first end 272A of second conductorhub 270B. In some examples, conductors 251-259 extend from first end272A to second end 272B of second conductor hub 272 relative tolongitudinal axis 525 of elongate lead body module 52. In some examples,each conductor of plurality of conductors 251-259 extend from first end272A to second end 272B of second conductor hub 270B, such that a secondportion 524B of conductors 251-259 extend beyond second end 272B ofsecond conductor hub 272. In some examples, lengths of the conductors ofsecond portion 524B may be long enough to reach a correspondingelectrode or connector contact or ring itself, such as may not requirethe use of a joint between modules.

In the example of FIG. 4D, conductors 251-259 are in a coiledarrangement between first end 521 of elongate lead body module 52 andsecond end of elongate lead body module 52. More particularly, in thisexample, the coiled arrangement extends between first conductor hub 270Aand second conductor hub 270B. In some examples first conductor hub 270Amay have a larger cross-sectional dimension (e.g., diameter) than secondconductor hub 270B. In some examples, second conductor hub 270B may havea larger cross-sectional dimension than first conductor hub 270A. Firstconductor hub 270A and second conductor hub 270B may be sized and shapedto for a desired purpose. In some examples, one or both of firstconductor hub 270A and second conductor hub 270B may not be required tofit inside an outer jacket (e.g., jacket module 54 or another sheath orcover). In some examples, one end of a conductor hub may include alarger outer cross-sectional dimension (e.g., diameter) than an innerdiameter of the outer jacket, such that only one end of the conductorhub may need to be inside (e.g., strung or passed through) the lumen ofthe outer jacket (e.g., the conductor hub may be further covered by amolding or a separate covering process). Elongate lead body module 52may have a straight arrangement of conductors 251-259 at first end 521and second end 522, such as to form a “straight to coiled to straight”arrangement of the conductors. Each of conductors 251-259 extendsthrough closed channels or conduits formed in hubs 270A and 270B to fixthe conductors 251-259 to the hubs. In other examples, the arrangementat first end 521 may be different than the arrangement at second end522. Likewise, first conductor hub 270A may include a different designthan second conductor hub 270B. Different examples of designs ofconductor hubs are disclosed herein, such as with reference to FIG. 5generally (e.g., FIG. 5A, FIG. 5B, etc.). As such, the arrangement ofthe conductors may be in a fixed arrangement on first end 521 and in adifferent fixed arrangement on second end 522. In some examples, thewinding apparatus described herein may secure both of first end 521 andsecond end 522 to a structure of the winding apparatus during winding.

In some examples, individual conductors 251-259 includes a single filarconfiguration. In other examples, the conductor includes a multi-filarconfiguration. In yet other examples, the conductor includes coils ofmulti-filar coils. For example, a first set of coiled filars and asecond set of coiled filars may be wound together, such as to form theconductor. The coiled arrangement of conductors of the elongate leadbody module may include one or more configurations of filars. Forexample, the coiled arrangement may include a single filar conductor, amulti-filar conductor, multiple sets of multi-filar conductors, or anycombination thereof.

FIG. 4B is a conceptual diagram illustrating an example of a portion ofmodular medical lead system 50 including electrode module 57. In oneexample, respective conductors 211-219 may extend from electrode module57. The respective conductors 211-219 may be coupled to correspondingconductors 251-259 of lead body module 52, for example. As discussedherein, the portion of the conductors that extend from conductor hubs270A or 270B may couple to other conductors of other modules (such as inthe example of FIG. 4B), or may connected directly to electrode module57, such as directly to electrodes 201-203, where electrodes 204-209 arenot shown, or directly to a portion of a housing or body of electrodemodule 57.

FIG. 4C is a conceptual diagram illustrating an example of a portion ofa modular medical lead system 50 that includes connector module 59.Respective conductors 231-239 of connector module 59 may be used toconnect conductors 251-259 of lead body module 52 to electrical contacts221-229. In another example, the portion of the conductors that extendbeyond conductor hub 270B may be directly coupled to electrical contacts221-229, or to a portion of a housing or body of connector module 59.Respective conductors 211-219 and 231-239 may comprise the same materialor insulated configuration as conductors 251-259.

FIG. 4E is a conceptual diagram illustrating an example of a portion ofa modular medical lead 50 including jacket module 54 surrounding aportion of elongate lead body module 52. Here it can be seen that jacketmodule 54 may be configured to cover conductors of module 52 to insulatethe conductors from environments such as inside patient 40. In anexample, the coiled arrangement of elongate lead body module 52 supportsthe modular architecture of the examples herein. In an example,conductors in the form of one or more cables (e.g., multiple groupedwires) may be used instead of the coiled arrangement of the example ofFIG. 4D, such as to provide an elongate lead body module. In otherexamples, one or more of the conductors is a cable and one or more ofthe conductors is a single wire. In one example, elongate lead bodymodule 52 includes a single cable comprising a plurality of wires (e.g.,nine wires), and the plurality of wires of the single cable may extendthrough one or more conductor hubs. In another example, the single cableitself may be used to connect two modules of modular medical lead system50.

In an example, for a coiled arrangement in elongate lead body module 52,such as after coil construction is completed, both ends may terminateand stabilized for presentations suitable to connect (e.g., weld) todistal and proximal ends (e.g., modules) of elongate lead body module52. In an example, the coiled arrangement may be strung into jacketmodule 54.

FIG. 4F is a conceptual diagram illustrating an example of a portion ofa modular medical lead system. In this example, electrode module 57 iscoupled to elongate lead body module 52. Conductor hub 271 presents theplurality of conductors in an arrangement suitable to weld or otherwiseelectrically couple to corresponding portions of electrode module 57.

In the example of FIG. 5G, a plurality of conductors are coupledconductor hub 270. Conductor hub 270 may maintain a desired presentation(“arrangement”) of the conductors. A portion of the conductors thatextend beyond conductor hub 270 may be ablated, such as may result inremoving an electrically insulating layer of the conductors. Conductorhub 270 may provide a circular presentation of the conductors, such asfor ease of coupling the conductors to another module. Otherpresentations may be used, such as to correspond to a cross-sectionalprofile of other modules. In the example of FIG. 5G, after exiting thechannels of conductor hub 270, conductors are positioned adjacentelectrically conductive portions of another module, such as forelectrically coupling the conductors to respective electrodes on anelectrode module. Conductors may be in coiled arrangement on one side ofconductor hub 270 and in a straight arrangement on the other side ofconductor hub 270.

In some examples, the channels of conductor hub 270 are through-holechannels. Conductor hub 270, in the example of FIG. 5G, is illustratedas partially transparent. As such channels of conductor hub 270 may beseen. In some examples, such as the channels shown are straight, such asmay be substantially parallel to the longitudinal axis of elongate leadbody module 52 or of conductor hub 270. In other examples, the channelsinclude a spiral shape, where the channels spiral around conductor hub270. The channels of conductor hub 270 may allow for handling of anindividual conductor of the plurality of conductors, such as to weld theindividual conductor to a respective conductor of another module, or toa portion of a housing of another module. Such handling may becontrolled, such as by providing the ability to manipulate theconductors without disturbing the coiled arrangement of conductors ofthe medial portion of elongate lead body 52.

FIG. 7C is a conceptual diagram illustrating an example portion ofmodular medical lead system 50. In the example shown, the distal ends ofthe plurality of conductors (e.g., conductor 251) extending beyond hub270 are aligned and joined with corresponding conductors of electrodemodule 57, e.g., via laser welding or other suitable technique. Asdescribed herein, conductor hub 270 may be used to form elongate leadbody module 52. Some examples of conductor hub 270 may be used as astarting conductor hub, such as for beginning to wind conductors aroundmandrel 124. Other examples of conductor hub 270 may be used as afinishing (or “terminating”) conductor hub, such as for securing asecond end of elongate lead body module 52 after a desired coiledarrangement is formed in the medial section of elongate lead body module52.

FIG. 7D is a conceptual diagram illustrating a cross section of anexample of modular medical lead system 50 shown in FIG. 7C. As shown,the conductors (e.g., conductor 251) having a radially symmetricarrangement past the conductor hub. The conductors of elongate lead bodymodule may transition, via conductor hub 270, from a straightarrangement to a straight arrangement of the electrode module 57 (e.g.,a “straight to straight” arrangement).

FIG. 7E illustrates another example cross section of modular medicallead system 50, such as may include conductors having an angled orhelical arrangement extending from the elongate lead body module 50. Inan example, respective conductors of an electrode module 57 (orconnector module 59), for example, may be in a straight arrangement,angled arrangement, or helical arrangement. As such, the conductors ofelongate lead body module 52 and respective conductors one or more othermodules may mate to each one another with a desired geometry. In someexamples, such a geometry may increase provide better accessibility toweld the conductors to one another. In the example of FIG. 7E, theconductors of the elongate lead body module 52 are shown in an angledarrangement, while the conductors of the electrode module 57 are shownin a straight arrangement (e.g., parallel to a longitudinal axis of theelectrode module 57) (e.g. a “angled to straight” arrangement).

In the example of FIG. 7F, the conductors (e.g., conductor 251) of theelongate lead body module 52 are shown in an angled arrangement, and theconductors of electrode module 57 are also shown in an angledarrangement (e.g., an “angled to angled” arrangement).

As noted above, some aspects of the disclosure relate to the exampleassembly system 100 shown in FIG. 2B. In some examples, assembly system100 may be used to manufacture a module lead body, such as, e.g., modulelead body 52. As described above, assembly system 100 may include anassembly apparatus 100. Assembly system 100 may include a winderapparatus 120. In some examples, these apparatuses may be positioned ata single station (e.g., a work station or a manufacturing station). Insome examples, these apparatuses may be positioned at separate stations(e.g., two different stations). Yet in other examples, assembly system100 comprises a combined assembly/winder apparatus. Assembly system 100may include automated portions, such as by using robotic arms, automatedcomputer systems, or the like. Example operation of assembly system 100,e.g., to form an elongate lead body module, is described further below.

FIGS. 9A-B are conceptual block diagrams of examples assembly apparatus110 and winder apparatus 120, respectively, of an assembly system, suchas assembly system 100 of FIG. 2B). As shown, assembly apparatus 110 mayinclude carriage 111, bobbins 112 rotatably coupled to carriage 111 viapins 113 extending from carriage 111. Assembly apparatus 110 may includea base 114. In an example, base 114 is used to secure the carriage forcoupling conductors to the conductor hub. In some examples, assemblyapparatus 110 include robotic arm 115.

Winder apparatus 120 may include driver 121, such as may be coupled tocone member 122. Cone member 122 may be coupled to winder head 123.Winder apparatus 120 may include mandrel 124. In an example, winderapparatus 120 includes one or more motors 125. In one example, there isa motor at each end of winder apparatus 120, such that two motors rotatein sync with each other to rotate mandrel 124 during the winding processto create the coiled arrangement of elongate lead body module 52. Insome examples, another motor is used, such as may be coupled to carriagemount 126. Carriage 111 may be mounted to carriage mount 126. And usinganother motor, carriage mount 126 may be moved along a longitudinal axisof mandrel 124. Mandrel 124 may extend through an opening defined bycarriage 111.

In an example, coiling the conductors around mandrel 124 includesrotating mandrel 124 with one or more motors 125, and creating distancebetween carriage mount 126 and the conductor hub comprises movingcarriage mount 126 away from the conductor hub causing the conductors tounwind from bobbins 112 and wind around mandrel 124. Bobbins 112 may becontrolled using brakes 127, in some examples. In some examples, winderapparatus 120 may not necessarily require brakes 127 (e.g., winderapparatus 120 may comprise a torque control system, a pad, a tensioningsystem, or an additional motor, such as to control the rate of bobbins112 angular motion). In other examples, coiling the conductor aroundmandrel 124 includes one or more of rotating carriage mount 126 inaddition to, or instead of rotating mandrel 124 or creating distancebetween the carriage mount 126 and the conductor hub is accomplished bymoving the mandrel and conductor hub away from carriage mount 126. Insome examples, the mandrel may move while the carriage mount 126 remainsin place (e.g., any relative motion of the mandrel and the carriagemount). Brakes 127 may be coupled to carriage mount 126. Assembly system100 may include control circuitry 128, such as to control portions ofwinder apparatus 120. In some examples, control circuitry 128 maycontrol portions of assembly apparatus 110, such as robotic arm 115.

In some examples, assembly apparatus 110 and winder apparatus 120 are apart of a manufacturing line, such as at two separate stations. In someexamples, assembly apparatus 110 and winder apparatus 120 are a part ofthe same apparatus (or same station), that may be partially or fullyautomated, such as may include using machine vision (e.g., video camerasand computers), to manufacture the elongate lead body module, forexample. In some examples, in forming elongate lead body module 52,assembly apparatus 100 and winder apparatus 120 may automatically,continue forming lead 50, such that the techniques described herein mayinclude forming lead 50 without necessarily requiring coupling more thantwo modules to one another as separate steps.

FIG. 9C is an image illustrating an example assembly system 100including winder apparatus 120 and portions of assembly apparatus 110for manufacturing a lead body module, such as, e.g., lead body module52. In FIG. 9C, winder apparatus 120 is shown on a table or aworkstation. Winder apparatus 120 may include motors 125A and 125B onopposite ends of winder apparatus 120. Mandrel 124 may extend from oneend to the other of winder apparatus 120. Winder head 123 may bemechanically coupled to motor 125A. Cone member 122 may be mechanicallycoupled to winder head 123. Driver 121 may be coupled to cone member122. In other examples driver 121 is coupled to winder head 123 or motor125A. In some examples, mandrel 124 is coupled to driver 121. In otherexamples, mandrel 124 is coupled to cone member 122 or winder head 123.In some examples, carriage 111 may include an interfacer to couple,align, register, or otherwise engage motor 125 and winder head 123, suchas may include not using a cone member (e.g., such as by using hubholder 275 as may be seen in FIG. 6F).

Carriage 111 may include a plurality of bobbins 112, such as may bearranged with radial symmetry on a side of carriage 111. Carriage 111may be mounted to carriage mount 126. Carriage mount 126 may be coupledto a plurality of brakes 127. Each brake of plurality of brakes 127 maycorrespond to a respective bobbin of plurality of bobbins 112. Carriagemount 126 may be coupled to another motor to move carriage mount 126 ina straight direction 132 away from the beginning side (e.g., with motor125A, as shown). Mandrel 125 may be rotated, such as by motors 125A and125B, in a rotational direction 131. In the example of FIG. 9C,rotational direction 131 is clockwise. In some examples, rotationaldirection 131 is counter-clockwise.

During the process to wind conductors around mandrel 124, mandrel 124rotates in rotational direction 131 and carriage mount moves in straightdirection 132, such as to cause the conductors wound around bobbins 112to coil around mandrel 124.

FIGS. 6A-R illustrate examples of components of assembly apparatus 110of assembly system 100. As shown in FIG. 6A, carriage 111 includes aplurality of pins, such as pin 113. A respective plurality of bobbinsmay be positioned on the plurality of pins, such as bobbin 112. In someexamples, conductor hub 270 is positioned within a central opening ofcarriage 111, such as before the winding process begins. FIG. 6Billustrates an example of carriage 111 from another view.

FIG. 6C illustrates an example of carriage 111 aligned to be mounted tocarriage mount 126 of a winder apparatus. Winder apparatus may include aplurality of brakes, such as brake 127. Each brake may correspond to arespective bobbin, such as to control a rotation rate during the windingprocess to manufacture the elongate lead body module.

FIG. 6D illustrates an example of carriage 111, such as coupled to acarriage base 114. Base 114 may be used to secure carriage 111, such aswhen mating the respective conductors to conductor hub 270. As can beseen from FIGS. 6C and 6D, carriage 111 may be coupled to a portion ofassembly apparatus in some examples, and may be coupled to a portion ofa winder apparatus in other examples. Generally, assembly apparatus 110may be used to position the conductors within the conductor hub 270.Generally, winder apparatus 120 may be used to coil the conductors toform the elongate lead body module, such as by using conductor hub 270as a starting hub or ending hub.

FIGS. 6E-H illustrate examples of carriage 111. For example, FIG. 6Hillustrates a central portion of carriage 111, such as may include guidewheels, where each individual conductor extends from the respectivebobbin, to a respective guide wheel, to a respective channel ofconductor hub 270.

FIGS. 6O-N illustrate examples of carriage 111. For examples FIG. 6Lillustrates an exploded view showing how brakes may be coupled tobobbins.

FIG. 6O illustrates an example of carriage 111. In this example, anindividual conductor extends from a single bobbin. As can be seen in theconceptual example of FIG. 6P, the individual conductor may mate withconductor hub 270, such as by being thread into a channel of conductorhub 270. A robotic arm may be automated to thread the conductor into thechannel of conductor hub 270, such as by using machine vision. In othernon-automated examples, a human operator may thread the conductor intothe channel. Such a process may be completed for each of the conductors251-259 of lead body module 52.

FIGS. 6Q-R illustrate examples of carriage 111. In some examples, thenumber of bobbins and pins may correspond to the number of conductors tobe included in the elongate leady body module.

FIG. 7A illustrates coiled conductors and conductor hub 270 for anelongate lead body module coupled to a portion of winder apparatus 120during a manufacturing step. Winder head 123 may be mechanically coupledto cone member 122. A motor (not shown) may be coupled to winder head123. A driver 121 may be coupled to cone member 122. Driver 121 may becoupled to conductor hub 270. In some examples, driver 121 is insertedinto an opening of conductor hub 270. In other examples, driver 121 isan external driver, such that conductor hub 270 fits within a portion ofdriver 121 (e.g., hub holder 274, such as may be seen in FIG. 6A). Asthe motor rotates, winder head 123, cone member, 122, driver 121,conductor hub 270, and a mandrel, such as shown in FIG. 7B, also rotatewith the motor.

FIG. 7B illustrates a conceptual example of a part of a method forassembling modular medical lead system 50. For example, as winder head123 is driven by a motor (not shown), a mandrel 124 rotates to windconductors around mandrel 124. In some examples, mandrel 124 is coupledto winder head 123 at least via conductor hub 270. In other examples,mandrel 124 is directly coupled such as to driver 121, such thatconductor hub 270 is slidably coupled to mandrel 124.

In the example of FIG. 7G, conductor hub 270 is a stabilizer hub. Thestabilizer hub may be coupled to mandrel 124 before winding begins. Or,in other examples, the stabilizer hub may be coupled to mandrel 124after winding the conductors into the coiled arrangement and beforespring-back of the coiled conductors occurs after the winding processhas stopped. In some examples, spring-back naturally occurs due to thecoiled arrangement of conductors.

As will be described below, a stabilizer hub may be temporarily usedduring a manufacturing process of lead body module 52 to drive andcontrol the unwinding (e.g., speed, amount, etc.) during spring backafter the coiling of conductors 251-259 is complete. From the stabilizerhub, the ordered conductors may be transferred to final hub or finishinghub used for lead body module 52, e.g., when joined with other modulesof modular lead 50.

In the conceptual example of FIG. 7H, conductor hub 270 is a spiral hub,such that the spiral hub includes grooved channels that are spiraledaround conductor hub 270. In an example, the spiral hub is used as afinishing conductor hub, such as to wind the plurality of conductorsover the hub. In some examples, the spiral hub is coupled to the coiledarrangement to form the second end of elongate lead body module 52. Inan example, the spiral hub is used to secure the conductors during thewinding process. In an example, the spiral hub presents the portion ofthe conductors that extend from the hub in an arrangement, such as astraight arrangement or a corresponding spiraled (e.g., helical)arrangement.

In the conceptual example of FIG. 7I, robotic arm 115 is configured toinclude a reach, an upward-downward movement, a rotation, such as tomove the arm in three dimensions. In some examples, robotic arm 115 isused to couple each conductor to a respective channel of conductor hub270. In one example, robotic arm 115 may thread the conductor into achannel of conductor hub 270, such as shown in FIG. 6P. Robotic arm 115may grasp the conductor, such as may extend from the bobbin of FIG. 6O,and guide the conductor to the channel of FIG. 6P, such as by usingassembly apparatus 100. In the conceptual illustration of FIG. 7J,portions of assembly apparatus 100 are shown. Examples of robotic arm115 may control one or more conductors, and position the conductors indesired locations. In other examples, a human operator may perform allor a portion of such functions. FIG. 7K includes another conceptualrobotic arm 115 configured to operate as described with respect to FIG.7I.

In some examples, the conductor hub fits the conductor pattern from thewinder apparatus before the tension is released, such as to match to theconductor pattern to the conductor hub. A tool and technique may be usedto move the wires into the conductor hub grooves before the tension isreleased. Once the conductor hub and presentation of conductors arecaptured, the tension or spring back may be allowed to happen.

FIGS. 10A-B illustrate examples of a method for assembling a modularmedical lead system. In the example of FIG. 10A, method 1000 is shown.At 1002, a plurality of conductors are coupled to a conductor hub. At1004, the plurality of conductors are coiled around a mandrel, such asto form the coiled arrangement of elongate lead body module 52. Featuresor techniques described herein may be used for steps 1002 and 1004, suchas one or more conductor hubs.

FIG. 10B illustrates an example of method 1100. Method 1100 may includeone or more of the following steps, and the steps may be rearranged tomanufacture, for example, elongate lead body module 52. At 1102, theplurality of conductors are wound around a respective plurality ofbobbins 112. At 1104, the bobbins 112 are positioned on pins 113 ofcarriage 111. At 1106, each conductor may be mated to a respectivechannel of conductor hub 270. In some examples, at 1110, carriage 111 istransferred from base 114 to carriage mount 126. At 1112, conductor hub270 may be interlocked with driver 121 and mandrel 124.

At 1114, one or more motors 125 may be activated, and the motors mayrotate the mandrel 124, such as through a connection between the motor125, the cone member 122, the driver 121 and the connector hub 270. At1116, carriage mount 126 may be moved, such as by using another motor,such as described herein. While the carriage mount 126 moves away fromconductor hub 270 and while mandrel rotates, at 1118 the conductors arecoiled around mandrel 124. Conductor hub 270 maintains the arrangementof the conductors for winding the conductors around the mandrel. At1120, the conductors are coupled to another conductor hub, such as thesecond conductor hub. In one example, this may include mating theconductors to channels of a stabilizer hub. In some examples, theconductors may be coupled to a finishing hub (e.g., the second conductorhub), and a subsequent step to secure the conductors to the finishinghub may include applying adhesive (e.g., glue) to secure the conductorsto the second hub, applying heat to reflow material around theconductors, snap fitting the conductors to the channels, performing ashort cleanup step, such as after applying a glue (e.g., to removeexcess glue), or any combination thereof. In some examples, coupling theconductors to the conductor hub may include temporarily clamping theconductors in place with a clamp configured to fit around the conductorhub and conductors to secure the conductors in place, and such a clampmay be removed in subsequent steps. At 1122, portions of the conductorsthat extend beyond the conductor hub can be sized to a desired lengthand ablated, such as to remove an electrically insulating coating. At1124, elongate lead body module is coupled to one or more other modules,such as to form modular medical lead system 50.

Method 1100 may include that two conductor hubs 270 are used, such asfor a starting hub and a finishing hub. In some examples, conductorsform a coiled arrangement after being coupled to conductor hub 270. Insome examples, conductors are couple to conductor hub 270 after beingformed into a coiled arrangement. In some examples, the conductors arefixed within the channels of conductor hub 270. In some examples, theconductors may slide or otherwise move within the channels as theconductor hub maintains the desired conductor arrangement provided bythe distribution of channels. After forming elongate lead body 52,mandrel 124 may be pulled out of the space defined by the coiledarrangement, and may be pulled out through a central opening ofconductor hub 270.

In some examples, the techniques and features herein may be combinedwith “hand winding” the conductors into the coiled arrangement. As suchthe conductor hub may aid in winding any coiled arrangement ofconductors.

In some examples, at 1120, the order of the conductors may be captured,such as by sliding conductor hub over mandrel 124 (e.g., as in FIG. 5D).In some examples, conductors are pulled or advanced from the winderapparatus (e.g., the mandrel) to form a bend (e.g., as FIG. 5E). In someexamples, conductors are locked, such as by adding a surrounding ringthat may be pressed, snap-fit, staked with heat or mechanically, gluedor molded to conductor hub 270 (e.g., as in FIG. 5F), such as mayinclude ordering the conductors to be ready for final conductordistribution hub. In some examples, a relatively small spring-backunwind process may occur after the desired presentation of conductors islocked.

In some examples, at 1120, stabilizer hub may capture the distributionof conductors while on the mandrel. The stabilizer hub may keepconductors ordered and in a known position as part of the windingprocess to aid in position the conductors for final presentation. Insome examples, final presentation may then be completed after winding,spring-back, and removal from the winder apparatus. The conductor hubmay be slid into the elongate lead body module after winding. In someexamples, conductor hub 270 may include a fingers shape that may act asa forming die as the conductors are pulled and locked into the grooves.In some examples, a stabilizer hub may include features to control theconductor forming transition from coil to desired presentation such asstraight or helix. It may also have a feature to immobilize the coiltransition area and protect it from being malformed during spring-back.In some examples, locking the transition area may be done by designvariants of the conductor hub 270, such as may include tape, adding asplit flexible surrounding ring, pressed, snap fit, staking with heat ormechanical, glued or molded (i.e. low temperature reflow). In someexamples, the stabilizer hub may be used with other mechanisms to driveand control the unwinding (speed, amount, etc.) during the spring-back.In some examples, after winding the coiled arrangement a mesh stabilizefeature with or without fingers may be coupled into winding pattern. Theconductor may be advanced to mesh stabilize feature to form theconductor arrangement. In some examples, an interim lock and controlledspring-back may allow spring-back and then the conductors will be readyfor final wire distribution.

FIGS. 8A-H are conceptual diagrams illustrating example aspects of amodular medical lead and systems during the manufacture of such modularleads. In an example, cone member 122 may include channels (such as inthe form of grooves as shown in the example of FIG. 8A), and conductorsmay extend from conductor hub 270, to be secured on cone member 122.Driver 121 may include channels, such as grooved channels. As can beseen from the transition from FIG. 8A to FIG. 8B, conductor hub 270 maybe interlocked with driver 121. Conductor hub 270 may be interlockedwith mandrel 124, such as before or after interlocking conductor hub 270with driver 121. Likewise, this coupling may allow for ease of removalafter elongate lead body 52 is formed. In the example of FIG. 8B, theconductors mate with the grooves of driver 121 and cone member 122. Insome examples, the grooves of driver 121 and cone member 122 align withone another, such as to secure the ends of the conductors during thecoil winding process.

FIG. 8C illustrates a conceptual example of portions assembly system 100and elongate lead body module 52 during the coiling process (alsoreferred to as winding process). In the example of FIG. 8D, firstconductor hub 270A may be coupled to driver 121. In an example, secondconductor hub 270B is used to form the second end of elongate lead bodymodule 52. For example, conductor hub 270B may be a stabilizer hub, aspiral hub, a hub having grooves, or another hub. In some examples, theexcess lengths of conductors may be cut, and portions of the remainingconductors extending from the respective conductor hubs 270A and 270Bmay be ablated, such as to remove electrically insulating material.

FIGS. 8E-H illustrate examples of the second conductor hub (e.g., alsomay be referred to as conductor hub 270, such as shown) toward the endof the winding process. The conductors may be organized using thefingers of the conductor hub. In the examples of FIGS. 8E and 8F, theconductors may be controlled using conductor hub 270, such as tomaintain the coil formed during the winding process. In the examples ofFIGS. 8G and 8H, conductor hub 270 may be configured to hold theconductors in place, as shown. In an example, a snap-member 289 may becoupled to each conductor, such as shown in FIG. 8H. The snap member 289may be an adhesive or a plastic ring or cylinder, in some examples. Thesnap-member 289 may help secure the conductors within the grooves of theconductor hub, such as in FIG. 8H.

FIGS. 5A-Q illustrate examples of portions of a modular medical leadsystem. In some examples of FIGS. 5A-Q, there are different designs ofconductor hub 270. In an example, conductor hub 270 includes a pluralityof channels 283 (only a single channel is labeled) extending between afirst end 281 and a second end 282 of conductor hub 270, such as may beseen in FIG. 5A. In the example of FIG. 5A, each channel 283 is athrough-hole type channel or conduit. Each channel 283 may correspond toa conductor of the elongate lead body module 52. The conductor may befixed in place within the channel 283. Or in some examples, theconductor is movably coupled to conductor hub 270, such that theconductor may slide relative to the conductor hub.

In the example of FIG. 5B, conductor hub 270 include channels 283 thatare grooved or recessed as compared to forming a closed channel as inFIG. 5A. To lock or otherwise fix the conductors within channels 283 ofhub 270 in an arrangement, design variants may include adding asurrounding ring or tape, which may be pressed, snap-fit, staked withheat or mechanically staked, glued, or molded (e.g., such as with a lowtemperature reflow). In some examples conductors of the elongate leadbody module are coupled to another module past conductor hub 270. Inother examples, conductors of the elongate lead body module are coupledto respective conductors of another module within a length of thegrooved channels, such as by welding or other coupling.

In the example of FIG. 5C, conductor hub 270 includes grooved channels283 that are spiraled around conductor hub 270, e.g., as opposed tosubstantially straight configuration between ends 281 and 282 for hub270 shown in FIG. 5A. In some examples, a density of the spirals (e.g.,rotations per length) is less than that of the coiled arrangement ofconductors of elongate lead body module 52. In some examples, thedensity of the spiral is substantially similar to or less than that ofthe coiled arrangement.

In the examples of FIGS. 5D-F, conductor hub 270 includes groovedchannels 283 (individual channel 283 labelled in FIG. 5D). In theseexamples, conductor hub 270 may be used as a conductor distribution hubfor coil winding, e.g., during the manufacturing process of lead bodymodule 52. In an example, conductor hub 270 with grooved channels (alsoreferred to as “grooves”) may include extensions 284 (or “fingers 284”)to capture and lock conductors, such as to provide a specifiedpresentation (or arrangement) while the conductors are ordered (such ason a winding head during manufacture). In some examples, the shape offingers 284 act as a forming die, such as when the individual conductorsare pulled and locked into the grooves 283. In some examples, to lockthe conductors in an arrangement, design variants may include adding asurrounding ring, which may be pressed, snap-fit, staked with heat ormechanically staked, glued, or molded (e.g., such as with a lowtemperature reflow). In an example, such a process includes, afterwinding the conductors in the coiled arrangement, the conductors may beadvanced straight to mesh into the grooves, locked into position, andmay allow for a spring-back due to the coil. In some examples, conductorhub 270 may not include protrusions 284 (or fingers 284), such as forease of manufacturing. In some examples, the grooves may bow, such as tobend conductors within the grooves. The grooves and the edges ofconductor hub 270 (such as at first and second ends 281, 282), may beused to form (e.g., bend) the conductors. In some examples, conductorhub 270 is used as an assembly tool, and removed after the desiredpresentation of the conductors is locked or secured.

In some examples, a conductor arrangement includes a straightarrangement, such as past conductor hub 270. In some examples, aconductor arrangement includes a helix. Other arrangements past thefirst end 281 or the second end 282 of conductor hub 270 may be used.Conductor hub 270 may be used to capture or secure conductors during thecoiling process of elongate lead body module 52. As such, conductor hubmay assure the presentation of the conductors before spring-back (e.g.,unwind) effect occurs. In some examples, conductor hub 270 forms wiresduring or after winding in short transition and diameters beyond‘bending’ (yield).

In the example of FIG. 5D, conductor hub 270 may capture an order of theconductors from a winder apparatus. Conductor hub 270 may slide over amandrel of the winder apparatus and into position next to the coiledarrangement, such as to secure the conductors. Conductor hub 270 mayinclude the finger shape to provide a forming die, such as for finishingthe winding process of the elongate lead body module.

In the example of FIG. 5E, conductors may be pulled or advanced from thewinder apparatus to form a bend over conductor hub 270. In someexamples, conductors may be pulled or advanced from the winder apparatusto form a bend without conductor hub 270, such as by bending theconductors themselves.

In the example of FIG. 5F, conductor hub 270 includes a lock feature. Insome examples, conductors may be secured to conductor hub 270, such asby adding a surrounding ring or tape, by pressing the conductors intoplace within grooves, by snap-fitting the conductors within grooves, bystaking with heat or staking mechanically, or glued or molded. In anexample, once the conductors are secured, the conductors may be orderedand ready to be coupled to another wire distribution hub, or anothermodule. A spring-back unwinding process may occur after the desiredpresentation is locked or secured.

In the example of FIG. 5H, conductor hub 270 may comprise a stabilizerhub. In an example, the stabilizer hub may include fingers to help incapturing the wire distribution on a winder. In an example, the fingersshape may act as a forming die as the wires are pulled and locked intothe grooves. In an example, the fingers may protect the transition areafrom unwanted bends during the spring-back unwind process, such as maybe a feature to immobilize the conductors in the coiled arrangement. Inan example, the stabilizer hub may include features to control the wireforming transition from coil to desired presentation such as straight orhelix. In an example, securing the transition area may be done by designvariants such as may include taping, adding a split flexible surroundingring, or other techniques described herein. In another example, thestabilizer may be used with other techniques or features to drive andcontrol the unwinding (speed, amount, etc.) during the spring-back. Inan example, conductor hub 270 may include lengthwise support for wiresused in next wire manufacturing process.

In the example of FIG. 5I, conductor hub 270 is illustrated in a sideview. Conductor hub 270 may include a through-hole extending from thefirst end to the second end of conductor hub 270. The plurality of wiresmay form an arrangement, such as may include having a diameter greaterthan the diameter of conductor hub 270.

In the example of FIG. 5J, conductor hub 270 includes an internal drivefeature. A driver 121 of winder apparatus 120 may be inserted inside theinternal drive feature, such as to couple conductor hub 270 to the motorof winder apparatus 120. Driver 121 may be coupled to a cone member 122of winder apparatus 120. In one example, cone member is a part of awinding head that may include the motor, such as to couple the motor tothe conductor hub 270. In another example, a mandrel of winder apparatus120 (not shown) may be coupled on the opposite end of conductor hub 270as driver 121, such that when the motor is activated, conductors may bewound around the mandrel as the motor rotates conductor hub 270.

In the example of FIG. 5K, conductor hub 270 is illustrated withconductors extending past its end, such as in an angled arrangement,such as to couple the conductors to respective portions of anothermodule.

In the example of FIG. 5L, conductor hub 270 is illustrated withconductors extending past its end, such as in a straight arrangement,such as to couple the conductors to respective portions of anothermodule. In the example of FIG. 5L, the portions of the conductors thatextend past conductor hub 270 are shown as coupling to a lead end modulein a side-by-side arrangement. For example, the conductors of extendingout of conductor hub 270 may be positioned in the same radial layer ofthe lead as the conductors of the lead end module. In some examples, theconductors that extend out of conductor hub 270 may be in an over-underarrangement with another module. FIG. 5T illustrates a top view of aconceptual example of a conductor and an electrode in such an over-underarrangement, as further described below. For example, the conductorsextending out of conductor hub 270 may be positioned at a larger radiusthan the conductors or connection contacts of the lead end module. In anexample, the conductors extending out of conductor hub 270 may bepositioned at a smaller radius than the conductors of the lead endmodule. In an example, during assembly, using the over-under arrangementmay allow for pushing the conductors into contact, which may makeangular orientation positioning of the modules easier.

In the example of FIG. 5M, conductor hub 270 is illustrated withconductors extending past its end, such as in a straight arrangement,such as to couple the conductors to respective portions of anothermodule. In this example, a snap-fit feature may be within grooves ofconductor hub 270.

In the example of FIG. 5N, conductor hub 270 is illustrated withconductors extending past its end, such as in a straight arrangement,such as to couple the conductors to respective conductors of anothermodule.

In the example of FIG. 5O, conductor hub 270 is illustrated withconductors extending past its end, such as in a circular arrangement,where the circular arrangement has a greater diameter than a diameter ofthe channels of conductor hub 270.

In the example of FIG. 5P, conductor hub 270 is illustrated withconductors extending past its end, such as in a straight arrangement,such as to couple the conductors to respective conductors of anothermodule.

In the example of FIG. 5Q, conductor hub 270 is illustrated withconductors extending past its end, such as in a straight arrangement,such as to couple the conductors to respective conductors of anothermodule. In this example, conductor connectors 273 may be used to coupleconductors of different modules to each other. This connection mayinclude a welded connection. In some examples, the connection is amechanical connection, such as by mechanically mating the conductors toeach other.

In the examples of FIGS. 5R and 5S, conductor hub 270 may be grooved.Conductor hub 270 may include an interlocking hub that may mate with theconductors on the winder apparatus, such as at an end of the wind length(e.g., the end of the coiled arrangement). FIG. 5R shows a portion ofhub 270 removed to illustrate the mating the mandrel about a centeraperture in hub 270. A tool may be used to assist the conductor hub tointerlock with the winder apparatus, and provide assistance to mate withother components of the assembly system. Conductor hub 270 may captureconductors before spring-back, such as to stabilize the terminating endof the coiled arrangement. As such, in an example, the conductors maynot move after spring-back (e.g., the coiled arrangement issubstantially secured after the initial spring-back). In one example,while the conductors are under tension, the tool may mesh the conductorhub into the coiled arrangement from the winder apparatus.

In the examples of FIGS. 5A-Q, conductor hub 270 may include an internaldrive feature or an external drive feature, such as for use as astarting hub when winding the coil around a mandrel. In these examples,conductor hub 270 may include an implant stylet lumen feature, such asan opening defined by a body of conductor hub 270. The opening ofconductor hub 270 may extend partially or fully through a length ofconductor hub 270. In an example, conductor hub 270 fits conductors orcrimped conductors. In an example, conductor hub 270 is machined. In anexample, conductor hub 270 is extruded. In an example, conductor hub 270is rigid. In an example, conductor hub 270 is elastomeric. In anexample, conductor hub 270 is a separate component from elongate leadbody module 52. In an example, conductor hub 270 is molded in place,such as starting mold hub or finishing mold hub, such as during themanufacture of elongate lead body module 52.

In the example, of FIG. 5T, conductor 251 is positioned over electrode201 in the over-under arrangement (e.g., presentation) described herein.Although conductor 251 is shown as having a smaller cross-sectionaldimension (e.g., diameter) than a width of electrode 201, any dimensionfor the electrodes (e.g., electrode 201) or conductors (e.g., conductor251) described herein may be used. In some examples, an electricalcontact of a lead-end module may be over the conductor of the leadmodule 50. FIG. 5U is an end view of the example over-under arrangementof conductor 251 and electrode 201 of FIG. 5T. Although illustrated as arectangle, conductor 251 may generally have a round cross-section.

In some examples, conductor hub 270 may stabilize or register conductorsso that the conductors are in a precise, known position. In theseexamples, conductor hub 270 may be configured to allow conductors toextend from conductor hub 270 in straight or angled arrangements. Inthese examples, conductors may be expanded, such that a diameter of thearrangement of the conductors is larger than a diameter of a medialportion of the elongate lead body module. Or, in these examples, anarrangement of the conductors extending form conductor hub 270 has asubstantially similar shape (e.g., diameter) as the medial portion ofthe elongate lead body module.

Conductor hub 270 may assist in coil winding termination, such as in astable, precise, and registered presentation. Channels of conductor hub270 may include through-hole, grooved, straight, angled, helical,locking, press or snap fit, other types of channels. Conductors may becoupled to conductor hub 270, such as by locking the transition areawith tape or another adhesive system. In some examples, a split flexiblesurrounding ring is coupled to a termination end of the elongate leadbody module during winding of conductors (e.g., such as by surroundingconductor hub 270 or directly onto the conductors).

In some examples, conductor hub 270 may be interlocked with the mandrelof the winder apparatus, such as during the manufacture of elongate leadbody module 52. In an example, conductor hub 270 captures thearrangement (e.g., the order) of the plurality of conductors before thewinding process begins. As such, conductor hub 270 may allow forautomation and mechanized assembly of modular medical lead system 50. Inone example this includes an automated robotic arm configured to couplethe plurality of conductors from bobbins at an assembly apparatus toconductor hub 270, such as at a respective plurality of channels ofconductor hub 270. In an example, a desired conductor arrangement isformed immediately adjacent to conductor hub 270, such as by using thetechniques and features disclosed herein. In an example, by using thetechniques and features herein (e.g., such as conductor hub 270), duringthe manufacture of elongate lead body module 52, irregular or longtransition sections may be reduced, such as relative to conventionallead manufacturing processes.

In some examples, the stabilizer hub may be installed before allowingspring-back. In some examples, the stabilizer hub maintains the order orarrangement of the conductors (e.g., a wound coil assembly of theelongate lead body module). In yet other examples, the techniques andfeatures disclosed herein allows the transfer or ordered conductorarrangement to termination of winding and presentation of an end portionof the conductors.

FIGS. 11A-11I illustrate examples of modular medical lead system 50.FIGS. 11A-11G show examples of an enlarged view (e.g., taken with a zoomcamera) of conductor hub 270. FIGS. 11H-11I are examples of a stabilizerhub. For example, FIGS. 11A, 11B, 11D, and 11E each illustrate anenlarged view of conductor hub 270. Conductors extend from the conductorhub 270. In some examples, such as shown in FIG. 11B, conductor hub 270may comprise more than one structure. In the example of FIG. 11B,conductor hub 270 may comprise a hub body component 261 and a hub sleevecomponent 262. For example, hub sleeve component 262 may be positionedover hub body component 261 to secure the conductors in place, such asbefore or after winding as described herein. In an example hub sleevecomponent 262 may be heat shrunk over hub body component 261. In someexamples, hub sleeve component 262 may comprise an elastic material,such as may be stretched over hub body component 261 and released totightly secure the conductors into place. In some examples, tape may bewound around stabilizer hub to secure the conductors. Any step hereinmay be performed either by automation or not by automation. For example,portions of method 1100 may be done by hand, such as by a humanoperator. In the example of FIG. 11F, conductor hub 270 is shown withconductors (e.g., conductor 251) in a coiled configuration.

FIGS. 12A-12H illustrate examples of conductor hub 270. In the examplesof FIGS. 12A-12D, conductor hub 270 is diagrammatically illustrated withdimensions having illustrated values. Each of the examples of FIGS.12A-12H include example dimensions that may be used for conductor hub270. In examples of FIGS. 12A-12H, conductor hub 270 includes aninternal drive feature (e.g., a component of conductor hub 270 having anaperture, such as described with respect to FIG. 5R), such as to coupleto driver 121. In the examples of FIGS. 12E-12H, an external driver 121may be used.

In some examples, a length of the elongate lead body module may includeabout 8 inches to about 36 inches. In some examples, the one or moreconductors are coiled for a length between the second end of the firstconductor hub and the first end of the second conductor hub, and whereinthe length is about 1 inch to about 50 inches, about 6 inches to about31 inches, or about 6 inches to about 36 inches. Other lengths arecontemplated. In some examples, elongate lead body module 52 may be usedfor different purposes, such as for one or more different electrodearrangements on different electrode modules. A stylet may be positionedinside elongate lead body 52.

While many of the foregoing examples consider use of multiple conductorswithin the elongate body, it will be understood that techniquesaccording to this disclosure apply with an elongate body having a singleconductor. Also, while many of the examples consider an implantable leador lead extension, these techniques apply to a module design for amedical system having one or more conductors carried by an elongatebody, with one or more ends of the one or more conductors beingelectrically isolated from any other of the one or more conductors andmechanically coupled to the conductor hub such that the one or moreconductors are in a fixed arrangement. These one or more conductors maybe coupled to any type of end module, such as an end module fordelivering electrical, optical, magnetic, chemical, or other type oftherapy, for providing optical, electrical or any other type ofmonitoring, for providing electrical and/or mechanical connectivity, orany other type of end module.

In some examples, a number of conductors may be different than a numberof channels in the conductor hub. For example, a modular medical leadsystem may include 8 conductors, and one or more conductor hubs mayinclude 9 channels each. In some examples, two conductor hubs of amodular medical lead system include different numbers of channels (e.g.,such as 8 channels in the first, and 9 channels in the second).

In some examples, at least one end of the conductor hub includes asmaller outer diameter than an inner diameter of the outer jacket (e.g.,a jacket module).

The above features and techniques are examples. Any suitable techniquesmay be used to fabricate the structures described herein and may varybased on the particular materials employed for the respectivecomponents.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments of the disclosure bepracticed. These embodiments are also referred to herein as “examples.”Such examples may include elements in addition to those shown ordescribed. However, the present inventors also contemplate examples inwhich only those elements shown or described are provided.

Clause 1: In one example, a modular medical lead system includes anelongate lead body module including a plurality of coiled electricalconductors extending from a first end to a second end of the elongatelead body module, and a conductor hub adjacent the first end of theelongate lead body module. The plurality of conductors are electricallyisolated from one another and mechanically coupled to the conductor hubsuch that the plurality of conductors are in a fixed arrangementrelative one another. A first end of the conductor hub is nearer thefirst end of the elongate lead body module than a second end of theconductor hub. Each of the plurality of conductors extend from the firstend to the second end of the conductor hub relative a longitudinal axisof the elongate lead body module such that a portion of the conductorsextend beyond the first end of the conductor hub, and wherein, for eachconductor, the portion of the conductor that extends beyond the firstend of the conductor hub is configured to be coupled to a respectiveelectrical conductor of a lead end module to allow respective electricalsignals to be conducted between the respective conductors of the leadend module and the conductors of the elongate lead body module.

Clause 2: In some examples of the modular medical lead system of clause1, the conductor hub comprises a first conductor hub, the elongate leadbody module further comprising a second conductor hub adjacent thesecond end of the elongate lead body, wherein the plurality ofconductors are electrically isolated from one another and mechanicallycoupled to the second conductor hub such that the plurality ofconductors are in a fixed arrangement relative to one another, wherein asecond end of the second conductor hub is nearer the second end of theelongate lead body module than a first end of the second conductor hub,and wherein the plurality of conductors extend from the first end to thesecond end of the second conductor hub relative to the longitudinal axisof the elongate lead body module.

Clause 3: In some examples of the modular medical lead system of clause2, each of the plurality of conductors extend from the first end to thesecond end of the second conductor hub such that a second portion of theconductors extend beyond the second end of the second conductor hub.

Clause 4: In some examples of the modular medical lead system of clause3, the modular medical lead system further comprises another lead endmodule, wherein, for each conductor, the second portion of the pluralityof conductors that extend beyond the second end of the second conductorhub is coupled to a respective electrical conductor of the another leadend module to allow the electrical signals to be conducted between therespective electrical conductor of the another lead end module and theconductor of the elongate lead body module.

Clause 5: In some examples of the modular medical lead system of any ofclauses 1-4, the conductor hub includes a plurality of channelsextending between the first end and the second of the conductor hub,wherein, each conductor is configured to mate with a correspondingchannel of the plurality of channels of the conductor hub.

Clause 6: In some examples of the modular medical lead system of clause5, the plurality of channels comprises at least one through-holeextending from the first end of the conductor hub to the second end ofthe conductor hub.

Clause 7: In some examples of the modular medical lead system of clause5 or 6, the plurality of channels comprises at least one groove into anouter surface of the conductor hub from first end of the conductor hubto the second end of the conductor hub.

Clause 8: In some examples of the modular medical lead system of any ofclauses 5-7, the plurality of channels includes 8 channels to 16channels.

Clause 9: In some examples of the modular medical lead system of any ofclauses 5-8, a total number of channels of the conductor hub is equal toa total number of conductors of the plurality of coiled electricalconductors.

Clause 10: In some examples of the modular medical lead system of any ofclauses 1-9, the conductor hub exhibits an annular cross section along aplane substantially orthogonal to the longitudinal axis of the elongatelead body module.

Clause 11: In some examples of the modular medical lead system of clause10, an outer diameter of the annular cross section is smaller than anouter diameter defined by the plurality of channels.

Clause 12: In some examples of the modular medical lead system of any ofclauses 1-11, the plurality of conductors are arranged substantiallycircumferentially equidistant from one another around the conductor hub.

Clause 13: In some examples of the modular medical lead system of any ofclauses 1-12, the plurality of conductors extend from the first end tothe second end of the conductor hub in a direction substantiallyparallel to the longitudinal axis of the elongate lead body module.

Clause 14: In some examples of the modular medical lead system of any ofclauses 1-13, the portion of the plurality of conductors that extendbeyond the first end extend in a direction relative to the longitudinalaxis of the elongate lead body module.

Clause 15: In some examples of the modular medical lead system of clause14, the direction relative to the longitudinal axis is a non-zero anglerelative to the longitudinal axis.

Clause 16: In some examples of the modular medical lead system of clause14 or 15, the direction relative to the longitudinal axis issubstantially parallel to the longitudinal axis.

Clause 17: In some examples of the modular medical lead system of any ofclauses 1-16, the plurality of coiled conductors in the elongate portiondefine an inner lumen, and wherein the conductor hub includes anaperture that is aligned substantially co-axially with the inner lumen.

Clause 18: In some examples of the modular medical lead system of any ofclauses 1-17, each conductor comprises a single conductive filament.

Clause 19: In some examples of the modular medical lead system of any ofclauses 1-18, at least one of the plurality of conductors comprises acable, wherein the cable includes more than one conductive filar.

Clause 20: In some examples of the modular medical lead system of any ofclauses 1-19, an outer jacket covering the plurality of coiledconductors and the conductor hub of the elongate lead body module, andwherein the jacket is comprised of an electrically non-conductingmaterial, and wherein the jacket is biocompatible.

Clause 21: In some examples of the modular medical lead system of any ofclauses 1-20, the first end of the conductor hub has a different outerdiameter than the second end of the conductor hub.

Clause 22: In some examples of the modular medical lead system of any ofclauses 1-21, the through-hole of the hub body includes a portion withan increasing diameter, wherein the diameter of the portion with theincreasing diameter increases from a distal fiducial relative to theproximal end of the hub body toward the proximal end of the hub body.

Clause 23: In some examples of the modular medical lead system of any ofclauses 1-22, the plurality of conductors extend out the distal end ofthe hub body in a distal arrangement.

Clause 24: In some examples of the modular medical lead system of clause23, the distal arrangement is a substantially circular shape.

Clause 25: In some examples of the modular medical lead system of clause24, the substantially circular shape includes a radius smaller than thecommon radius of the plurality of channels of the first conductor hub.

Clause 26: In some examples of the modular medical lead system of clause24, the substantially circular shape includes a radius larger than thecommon radius of the plurality of channels of the first conductor hub.

Clause 27: In some examples of the modular medical lead system of clause23, the distal arrangement is shaped to couple to a separate module,wherein the separate module includes one of an electrode module, aconnector module, or another elongate portion.

Clause 28: In some examples of the modular medical lead system of any ofclauses 1-27, the conductor hub exhibits a substantially cylindricallyshape.

Clause 29: In some examples of the modular medical lead system of any ofclauses 1-28, the plurality of conductors extend out the second end ofthe hub body in a direction relative to the longitudinal axis of thefirst conductor hub.

Clause 30: In some examples of the modular medical lead system of clause29, the direction includes two non-zero angles in two respectivedimensions.

Clause 31: In some examples of the modular medical lead system of any ofclauses 1-29, the conductor hub is a single piece.

Clause 32: In some examples of the modular medical lead system of any ofclauses 1-30, the conductor hub is configured to transition theplurality of conductors from a proximal arrangement to a distalarrangement.

Clause 33: In some examples of the modular medical lead system of clause32, the proximal arrangement is a coiled arrangement, and the distalarrangement is a coiled arrangement.

Clause 34: In some examples of the modular medical lead system of clause32, the proximal arrangement is a coiled arrangement, and the distalarrangement is a straight arrangement.

Clause 35: In some examples of the modular medical lead system of clause32, the proximal arrangement is a straight arrangement, and the distalarrangement is a straight arrangement.

Clause 36: In some examples of the modular medical lead system of any ofclauses 1-35, a through-hole of the hub body is sized to fit a mandrelwithin the through-hole.

Clause 37: In some examples of the modular medical lead system of any ofclauses 1-36, the first conductor hub is configured to couple to a drivecomponent, and wherein the first conductor hub is configured to wind theplurality of conductors around a mandrel to manufacture the elongateportion.

Clause 38: In some examples of the modular medical lead system of clause37, a portion of the drive component is positioned within a through-holeof the hub body, and wherein the drive component extends at leastpartially into the through-hole of the hub body.

Clause 39: In some examples of the modular medical lead system of clause37, the first conductor hub is configured to fit within the drivecomponent, wherein the drive component comprises an external drivecomponent.

Clause 40: In some examples of the modular medical lead system of clause2, the plurality of conductors are coiled for a length between thesecond end of the first conductor hub and the first end of the secondconductor hub, and wherein the length is about 6 inches to 36 inches.

Clause 41: In some examples of the modular medical lead system of any ofclauses 1-40, the modular medical lead system further includes the leadend module, wherein, for each conductor, the portion of the conductorthat extends beyond the first end of the conductor hub is coupled to therespective electrical conductor of the lead end module to allowrespective electrical signals to be conducted between the respectiveconductors of the lead end module and the conductors of the elongatelead body module.

Clause 42: In some examples of the modular medical lead system of any ofclauses 1-41, the modular medical system is any of a medical lead, alead extension, a screening device, a diagnostic device or a monitoringdevice.

Clause 43: In some examples, a medical device systems comprises themodular medical lead system of any of clauses 1-42; and a medicaldevice, wherein the medical device is configured to at least one ofdeliver electrical stimulation to a patient or sense electrical signalof the patient via the plurality of conductors.

Clause 44: In some examples, a method comprises at least one ofdelivering electrical stimulation to a patient or sensing electricalsignals of the patient via the medical device system of clause 43.

Clause 45: In some examples, a method comprises forming the modular leadsystem of any of clauses 1-42, wherein forming the modular lead systemincludes: coiling the plurality of electrical conductors; andmechanically coupling the plurality of electrical conductors to theconductor hub such that the plurality of conductors are in a fixedarrangement relative one another.

Clause 46: In some examples of the method of clause 45, the plurality ofelectrical conductors are mechanically coupled to the conductor hubprior to coiling the plurality of electrical conductors.

Clause 47: In some examples of the method of clause 45, the plurality ofelectrical conductors are mechanically coupled to the conductor hubafter coiling the plurality of electrical conductors.

Clause 48: In some examples of the method of any of clauses 45-47, themethod further comprises coupling, for each conductor, the portion ofthe conductor that extends beyond the first end of the conductor hub toa respective electrical conductor of a lead end module to allowrespective electrical signals to be conducted between the respectiveconductors of the lead end module and the conductors of the elongatelead body module.

Clause 49: In some examples a conductor hub for a modular medical leadsystem comprises a hub body including a through-hole extending from afirst end of the hub body to a second end of the hub body; and aplurality of channels positioned around the conductor hub, whereinrespective longitudinal axes of the plurality of channels aresubstantially parallel to a longitudinal axis of the conductor hub,wherein the plurality of channels are positioned at a common radius fromthe longitudinal axis of the conductor hub.

Clause 50: In some examples of the conductor hub of clause 49, eachchannel defines a through-hole extending from the first end of the hubbody to the second end of the hub body.

Clause 51: In some examples of the conductor hub of clause 49 or 50,each channel defines a groove on an outer surface of the hub body, eachgroove extending from the first end of the hub body to the second end ofthe hub body, wherein an outer profile of the hub body includes thegrooves.

Clause 52: In some examples of the conductor hub of any of clauses49-51, the plurality of channels includes 8 channels to 16 channels.

Clause 53: In some examples of the conductor hub of any of clauses49-52, the conductor hub is substantially cylindrically shaped.

Clause 54: In some examples of the conductor hub of any of clauses49-53, a radius of the through-hole of the hub body is smaller than thecommon radius of the plurality of channels.

Clause 55: In some examples of the conductor hub of any of clauses49-54, the plurality of channels are circumferentially equidistant fromone another.

Clause 56: In some examples of the conductor hub of any of clauses49-55, a diameter of each channel is about 0.152 millimeters.

Clause 57: In some examples of the conductor hub of any of clauses49-56, a diameter of a circle defined by the plurality of channels isabout 0.762 millimeters.

Clause 58: In some examples of the conductor hub of any of clauses49-57, the through-hole of the hub body is configured to fit over amandrel used to assemble the modular medical lead system.

Clause 59: In some examples of the conductor hub of any of clauses49-58, the conductor hub is configured to couple to a drive component,and wherein the conductor hub is configured to wind a plurality ofconductors around a mandrel to manufacture the modular medical leadsystem.

Clause 60: In some examples of the conductor hub of clause 59, theconductor hub comprises the drive component, wherein a portion of thedrive component is positioned at least partially within the through-holeof the hub body, and wherein the drive component extends at leastpartially into the through-hole of the hub body.

Clause 61: In some examples of the conductor hub of clause 59, theconductor hub is configured to fit within the drive component, whereinthe drive component is an external drive component.

Clause 62: In some examples of the conductor hub of any of clauses49-61, the conductor hub is configured to house a plurality ofconductors within the respective channels, and wherein the conductor hubis configured to direct the plurality of conductors to extend out of thechannels in a direction relative to the longitudinal axis of theconductor hub.

Clause 63: In some examples of the conductor hub of clause 62, thedirection relative to the longitudinal axis of the conductor hub isparallel to the longitudinal axis of the conductor hub.

Clause 64: In some examples of the conductor hub of clause 62, thedirection relative to the longitudinal axis of the conductor hub is at anon-zero angle relative to the longitudinal axis of the conductor hub.

Clause 65: In some examples of the conductor hub of clause 62, thedirection relative to the longitudinal axis is angled such that theplurality of conductors form a coiled configuration

Clause 66: In some examples of the conductor hub of any of clauses49-65, the plurality of channels are substantially straight from thefirst end of the hub body to the second end of the hub body

Clause 67: In some examples of the conductor hub of any of clauses49-66, the through-hole of the hub body includes a portion with anincreasing diameter, wherein the diameter of the through-hole increasesfrom a medial portion of the hub body toward the second end of the hubbody.

Clause 68: In some examples of the conductor hub of any of clauses49-67, the conductor hub is configured to be placed within an outerjacket.

Clause 69: In some examples of the conductor hub of any of clauses49-68, the first end of the hub body has a different outer diameter thanthe second end of the hub body.

Clause 70: In some examples, a method for forming an elongate lead bodymodule of a modular lead comprises rotating a mandrel, wherein themandrel extends through a through-hole of a conductor hub, wherein aplurality of conductors extend through a respective plurality ofchannels of the conductor hub, the conductors extending from arespective plurality of bobbins to the channels, wherein the bobbins arecoupled to a carriage, the carriage defining central opening throughwhich the mandrel passes; and moving the carriage away from theconductor hub along a length of the mandrel while the mandrel rotatescausing the conductors to coil around the mandrel.

Clause 71: In some examples of the method of clause 70, the methodfurther comprises coupling the conductor hub with the mandrel.

Clause 72: In some examples of the method of clause 70 or 71, a startingposition of the carriage is adjacent to the conductor hub in a directionof a longitudinal axis of the mandrel, such that the conductors begin tocoil around the mandrel adjacent to the conductor hub.

Clause 73: In some examples of the method of any of clauses 70-72,rotating the mandrel includes using a motor, wherein the mandrel iscoupled to the motor, and wherein the mandrel rotates at the same rateas the motor.

Clause 74: In some examples of the method of any of clauses 70-73, themethod further comprises threading the plurality of conductors withinthe respective plurality of channels.

Clause 75: In some examples of the method of clause 74, the threading isperformed by a robotic assembly machine.

Clause 76: In some examples of the method of any of clauses 70-75, themethod further comprises automating the forming of the elongate portionusing processor circuitry, the processor circuitry communicativelycoupled to the robotic assembly machine.

Clause 77: In some examples of the method of any of clauses 70-76, themethod further comprises controlling a rate at which the bobbinsdispense the conductors while moving the carriage.

Clause 78: In some examples of the method of clause 77, controlling therate at which the bobbins dispense the conductors includes using aplurality of brakes, each bobbin coupled to a respective brake.

Clause 79: In some examples of the method of any of clauses 70-78, themethod further comprises stabilizing the conductors using a stabilizeronce a coiled section of the elongate portion has reached a specifiedlength, wherein stabilizing the conductors includes fixing theconductors in respective channels of the stabilizer to maintain thecoiled configuration of the coiled section.

Clause 80: In some examples of the method of any of clauses 70-79, themethod further comprises stabilizing the conductors using a secondconductor hub once a coiled section of the elongate portion has reacheda specified length, wherein stabilizing the conductors includes couplingthe conductors with respective channels of the second conductor hub, andwherein the channels of the second conductor hub are grooved channels.

Clause 81: In some examples of the method of any of clauses 70-80, themethod further comprises assembling the carriage, the bobbins, and athreaded conductor hub on an assembly.

Clause 82: In some examples of the method of clause 82, the methodfurther comprises transferring the assembly to a system including themotor for rotating the mandrel with the assembly.

Clause 83: In some examples of the method of clause 74, threading isperformed by an automated assembly machine.

Clause 84: In some examples, a method for forming a modular leadcomprises coiling a plurality of electrical conductors around a mandrel,wherein the mandrel is coupled to a conductor hub, wherein theconductors are mechanically coupled to the conductor hub such that theplurality of conductors are in a fixed arrangement relative to oneanother, wherein coiling the conductors includes coiling the conductorsalong a length of the mandrel, wherein the plurality of conductorsextend from a respective plurality of bobbins coupled to a carriage, thecarriage defining a central opening through which the mandrel extends,and wherein coiling the conductors includes moving at least one of themandrel and the carriage relative to each other angularly andlongitudinally, wherein the relative longitudinal movement occurs alonga longitudinal axis of the mandrel, and wherein the relative angularmovement occurs such that an orientation of the mandrel and anorientation of the carriage rotate relative to each other.

Clause 85: In some examples of the method of clause 84, moving themandrel and the carriage relative to each other includes rotating themandrel around the longitudinal axis of the mandrel and maintaining theorientation of the carriage, and wherein the carriage moves in adirection away from the conductor hub along the longitudinal axis of themandrel.

Clause 86: In some examples of the method of clause 84 or 85, the methodfurther comprises mechanically coupling the conductors to the conductorhub before coiling the conductors around the mandrel.

Clause 87: In some examples of the method of clause 86, mechanicallycoupling comprises mating the conductors with a respective plurality ofchannels extending between a first end of the conductor hub to a secondend of the conductor hub.

Clause 88: In some examples of the method of clause 86, mechanicallycoupling the conductors to the conductor hub includes positioning theconductors into a respective plurality of through-hole channelsextending between a first end of the conductor hub to a second hub ofthe conductor hub.

Clause 89: In some examples of the method of clause 86, mechanicallycoupling the conductors to the conductor hub includes roboticallypositioning the conductors into a respective plurality of channelsextending between a first end of the conductor hub to a second hub ofthe conductor hub, and wherein robotically positioning the conductorsincludes using a robotic conductor positioning arm.

Clause 90: In some examples of the method of any of clauses 84-89,moving at least one of the mandrel and the carriage includes causing theconductors to unwind from the bobbins.

Clause 91: In some examples of the method of clause 90, unwinding theconductors from the bobbins includes controlling an angular velocity ofthe bobbins using a respective plurality of brakes, each bobbin coupledto a respective brake.

Clause 92: In some examples of the method of any of clauses 85-91, themethod further comprises coupling the conductor hub with the mandrelbefore rotating the mandrel.

Clause 93: In some examples of the method of any of clauses 84-92, themethod further comprises winding the conductors around the bobbins.

Clause 94: In some examples of the method of any of clauses 84-93, thebobbins are coupled to the carriage by positioning the bobbins on thecarriage in a radially symmetric arrangement on the carriage.

Clause 95: In some examples of the method of any of clauses 84-94, themethod further comprises positioning the carriage on a windingapparatus, wherein the winding apparatus includes the mandrel.

Clause 96: In some examples of the method of any of clauses 84-95, thecarriage moves in a direction away from the conductor hub along thelongitudinal axis of the mandrel, and wherein a starting position of thecarriage is adjacent to the conductor hub in a direction of alongitudinal axis of the mandrel, such that the conductors begin coilingaround the mandrel adjacent to the conductor hub.

Clause 97: In some examples of the method of any of clauses 85-96,rotating the mandrel includes using a motor, wherein the mandrel iscoupled to the motor.

Clause 98: In some examples of the method of any of clauses 84-97, themethod further comprises forming an end section of the modular leadafter coiling the conductors along the length, wherein the conductor hubcomprises a first conductor hub, wherein forming the end section of themodular lead includes coupling a second conductor hub to the pluralityof conductors at the end section.

Clause 99: In some examples of the method of clause 98, the methodfurther comprises coupling the conductors to a respective plurality ofchannels of the second conductor hub.

Clause 100: In some examples of the method of clause 99, the methodfurther comprises coupling the conductors to the respective channels,wherein the channels are grooves, and wherein coupling the conductors tothe respective channels includes mating the conductors to the respectivegrooves.

Clause 101: In some examples of the method of clause 100, the methodfurther comprises capturing the conductors within a plurality ofrespective slots defined by a respective plurality of protrusions of thesecond conductor hub, wherein the grooves include the slots.

Clause 102: In some examples of the method of clause 103, the methodfurther comprises securing the conductors to the second conductor hub byat least one of: pressing the conductors into the grooves, dispensing anadhesive to secure the conductors within the grooves, providing apressure onto the conductors to snap-fit the conductors within thegrooves, or staking the conductors using heat.

Clause 103: In some examples of the method of any of clauses 98-102,coupling the second conductor hub to the conductors includes maintainingan arrangement of the conductors using a stabilizer hub after coilingthe conductors along the length.

Clause 104: In some examples of the method of clause 90, unwinding theconductors from the bobbins includes controlling a tension of theconductors using a respective plurality of brakes, each bobbin coupledto a respective break.

Clause 105: In some examples of the method of any of clauses 84-104, themethod further comprises interlocking the carriage on a winder apparatussuch that the mandrel, the conductor hub, and the winder apparatus arecoupled to one another, wherein the winder apparatus includes themandrel.

Clause 106: In some examples a system for assembling a modular medicallead comprises, a winder apparatus including a mandrel extending from afirst section to a second section of the winder apparatus, a motorcoupled to the mandrel in the first section, a carriage mount configuredto couple to a carriage, wherein the mandrel extends through an openingdefined by the carriage, and wherein the carriage mount is configured tomove along in a direction of a longitudinal axis of the mandrel.

Clause 107: In some examples of the system of clause 106, the systemfurther comprises an assembly apparatus including a base configured tocouple to a carriage, the based configured to secure the carriage whilecoupling bobbins to the carriage and while coupling conductors extendingfrom the bobbins to a conductor hub.

Clause 108: In some examples of the system of clause 107, the systemfurther comprises a robotic arm configured to couple the conductors tothe conductor hub.

Clause 109: In some examples of the system of any of clauses 106-108,the system further comprises brakes coupled to the carriage mount, thebrakes coupled to respective bobbins to control an angular velocity ofthe bobbins.

Clause 110: In some examples of the system of clauses 107, the systemfurther comprises an automation system configured to couple theconductors to the conductor hub.

Clause 111: In some examples of the system of any of clauses 106-110,the system further comprises brakes coupled to the carriage mount, thebrakes coupled to respective bobbins to control a tension of theconductors.

Clause 112: In some examples, a modular medical system comprises anelongate body module including one or more coiled electrical conductorsextending from a first end to a second end of the elongate body module,and a conductor hub adjacent the first end of the elongate body module,wherein the one or more conductors are electrically isolated from anyother of the one or more conductors and mechanically coupled to theconductor hub such that the one or more conductors are in a fixedarrangement, wherein a first end of the conductor hub is nearer thefirst end of the elongate body module than a second end of the conductorhub, wherein each of the one or more conductors extend from the firstend to the second end of the conductor hub relative a longitudinal axisof the elongate body module such that a portion of the conductors extendbeyond the first end of the conductor hub, and wherein, for eachconductor, the portion of the conductor that extends beyond the firstend of the conductor hub is configured to be coupled to a respectiveelectrical conductor of a lead end module to allow respective electricalsignals to be conducted between the respective conductors of the leadend module and the conductors of the elongate body module.

Clause 113: In some examples of the modular medical system of clause112, the conductor hub comprises a first conductor hub, the elongatebody module further comprising a second conductor hub adjacent thesecond end of the elongate body, wherein the one or more conductors areelectrically isolated from one another and mechanically coupled to thesecond conductor hub such that the one or more conductors are in a fixedarrangement relative to one another, wherein a second end of the secondconductor hub is nearer the second end of the elongate body module thana first end of the second conductor hub, and wherein the one or moreconductors extend from the first end to the second end of the secondconductor hub relative to the longitudinal axis of the elongate bodymodule.

Clause 114: In some examples of the modular medical system of clause113, each of the one or more conductors extend from the first end to thesecond end of the second conductor hub such that a second portion of theconductors extend beyond the second end of the second conductor hub.

Clause 115: In some examples of the modular medical system of clause114, the modular medical system further comprises another lead endmodule, wherein, for each conductor, the second portion of the one ormore conductors that extend beyond the second end of the secondconductor hub is coupled to a respective electrical conductor of theanother lead end module to allow the electrical signals to be conductedbetween the respective electrical conductor of the another lead endmodule and the conductor of the elongate body module.

Clause 116: In some examples of the modular medical system of any ofclauses 112-115, the conductor hub includes one or more channelsextending between the first end and the second of the conductor hub,wherein, each conductor is configured to mate with a correspondingchannel of the one or more channels of the conductor hub.

Clause 117: In some examples of the modular medical system of clause116, the one or more channels comprises at least one through-holeextending from the first end of the conductor hub to the second end ofthe conductor hub.

Clause 118: In some examples of the modular medical system of clause116, the one or more channels comprises at least one groove into anouter surface of the conductor hub from first end of the conductor hubto the second end of the conductor hub.

Clause 119: In some examples of the modular medical system of clause116, the one or more channels includes 8 channels to 16 channels.

Clause 120: In some examples of the modular medical system of clause116, a total number of channels of the conductor hub is equal to a totalnumber of conductors of the one or more coiled electrical conductors.

Clause 121: In some examples of the modular medical system of any ofclauses 112-120, the conductor hub exhibits an annular cross sectionalong a plane substantially orthogonal to the longitudinal axis of theelongate body module.

Clause 122: In some examples of the modular medical system of clause121, an outer diameter of the annular cross section is smaller than anouter diameter defined by the one or more channels.

Clause 123: In some examples of the modular medical system of any ofclauses 112-122, the one or more conductors are arranged substantiallycircumferentially equidistant from one another around the conductor hub.

Clause 124: In some examples of the modular medical system of any ofclauses 112-123, the one or more conductors extend from the first end tothe second end of the conductor hub in a direction substantiallyparallel to the longitudinal axis of the elongate body module.

Clause 125: In some examples of the modular medical system of any ofclauses 112-124, the portion of the one or more conductors that extendbeyond the first end extend in a direction relative to the longitudinalaxis of the elongate body module.

Clause 126: In some examples of the modular medical system of clause125, the direction relative to the longitudinal axis is a non-zero anglerelative to the longitudinal axis.

Clause 127: In some examples of the modular medical system of clause125, the direction relative to the longitudinal axis is substantiallyparallel to the longitudinal axis.

Clause 128: In some examples of the modular medical system of any ofclauses 112-127, the one or more coiled conductors in the elongateportion define an inner lumen, and wherein the conductor hub includes anaperture that is aligned substantially co-axially with the inner lumen.

Clause 129: In some examples of the modular medical system of any ofclauses 112-128, each conductor comprises a single conductive filament.

Clause 130: In some examples of the modular medical system of any ofclauses 112-129, at least one of the one or more conductors comprises acable, wherein the cable includes more than one conductive filar.

Clause 131: In some examples of the modular medical system of any ofclauses 112-130, the modular medical system further comprises an outerjacket covering the one or more coiled conductors and the conductor hubof the elongate body module, and wherein the jacket is comprised of anelectrically non-conducting material, and wherein the jacket isbiocompatible.

Clause 132: In some examples of the modular medical system of any ofclauses 112-131, the first end of the conductor hub has a differentouter diameter than the second end of the conductor hub.

Clause 133: In some examples of the modular medical system of any ofclauses 112-132, the through-hole of the hub body includes a portionwith an increasing diameter, wherein the diameter of the portion withthe increasing diameter increases from a distal fiducial relative to theproximal end of the hub body toward the proximal end of the hub body.

Clause 134: In some examples of the modular medical system of any ofclauses 112-133, the one or more conductors extend out the distal end ofthe hub body in a distal arrangement.

Clause 135: In some examples of the modular medical system of clause134, the distal arrangement is a substantially circular shape.

Clause 136: In some examples of the modular medical system of clause 135the substantially circular shape includes a radius smaller than thecommon radius of the one or more channels of the first conductor hub.

Clause 137: In some examples of the modular medical system of clause135, the substantially circular shape includes a radius larger than thecommon radius of the one or more channels of the first conductor hub.

Clause 138: In some examples of the modular medical system of clause 134the distal arrangement is shaped to couple to a separate module, whereinthe separate module includes one of an electrode module, a connectormodule, or another elongate portion.

Clause 139: In some examples of the modular medical system of any ofclauses 112-138, the conductor hub exhibits a substantiallycylindrically shape.

Clause 140: In some examples of the modular medical system of any ofclauses 112-139, the one or more conductors extend out the second end ofthe hub body in a direction relative to the longitudinal axis of thefirst conductor hub.

Clause 141: In some examples of the modular medical system of clause140, the direction includes two non-zero angles in two respectivedimensions.

Clause 142: In some examples of the modular medical system of any ofclauses 112-141, the conductor hub is a single piece.

Clause 143: In some examples of the modular medical system of any ofclauses 112-142, the conductor hub is configured to transition the oneor more conductors from a proximal arrangement to a distal arrangement.

Clause 144: In some examples of the modular medical system of clause143, the proximal arrangement is a coiled arrangement, and the distalarrangement is a coiled arrangement.

Clause 145: In some examples of the modular medical system of clause143, the proximal arrangement is a coiled arrangement, and the distalarrangement is a straight arrangement.

Clause 146: In some examples of the modular medical system of clause143, the proximal arrangement is a straight arrangement, and the distalarrangement is a straight arrangement.

Clause 147: In some examples of the modular medical system of any ofclauses 112-146, a through-hole of the hub body is sized to fit amandrel within the through-hole.

Clause 148: In some examples of the modular medical system of any ofclauses 112-147, the first conductor hub is configured to couple to adrive component, and wherein the first conductor hub is configured towind the one or more conductors around a mandrel to manufacture theelongate portion.

Clause 149: In some examples of the modular medical system of clause148, a portion of the drive component is positioned within athrough-hole of the hub body, and wherein the drive component extends atleast partially into the through-hole of the hub body.

Clause 150: In some examples of the modular medical system of clause148, the first conductor hub is configured to fit within the drivecomponent, wherein the drive component comprises an external drivecomponent.

Clause 151: In some examples of the modular medical system of clause113, the one or more conductors are coiled for a length between thesecond end of the first conductor hub and the first end of the secondconductor hub, and wherein the length is about 6 inches to about 36inches.

Clause 152: In some examples of the modular medical system of any ofclauses 112-152, the modular medical system further comprises the leadend module, wherein, for each conductor, the portion of the conductorthat extends beyond the first end of the conductor hub is coupled to therespective electrical conductor of the lead end module to allowrespective electrical signals to be conducted between the respectiveconductors of the lead end module and the conductors of the elongatebody module.

Clause 153: In some examples of the modular medical system of any ofclauses 112-152, the modular medical system is any of a medical lead, alead extension, a screening device, a diagnostic device or a monitoringdevice.

Clause 154: In some examples, a medical device system comprises themodular medical lead system of any of clauses 112-153; and a medicaldevice, wherein the medical device is configured to at least one ofdeliver electrical stimulation to a patient or sense electrical signalof the patient via the plurality of conductors.

Clause 155: In some examples, a method comprises at least one ofdelivering electrical stimulation to a patient or sensing electricalsignals of the patient via the medical device system of clause 154.

Clause 156: In some examples, a method comprises forming the modularlead system of any of clauses 112-153, wherein forming the modular leadsystem includes: coiling the one or more electrical conductors; andmechanically coupling the one or more electrical conductors to theconductor hub such that the one or more conductors are in a fixedarrangement relative one another.

Clause 157: In some examples of the method of clause 156, the one ormore electrical conductors are mechanically coupled to the conductor hubprior to coiling the plurality of electrical conductors.

Clause 158: In some examples of the method of clause 156, the one ormore conductors are mechanically coupled to the conductor hub aftercoiling the plurality of electrical conductors.

Clause 159: In some examples of the method of clause 156, the methodfurther comprises coupling, for each conductor, the portion of theconductor that extends beyond the first end of the conductor hub to arespective electrical conductor of a lead end module to allow respectiveelectrical signals to be conducted between the respective conductors ofthe lead end module and the one or more conductors of the elongate leadbody module.

These examples may be combined in any permutation or combination.

Moreover, the present inventors also contemplate examples using anycombination or permutation of those elements shown or described (or oneor more aspects thereof), either with respect to a particular example(or one or more aspects thereof), or with respect to other examples (orone or more aspects thereof) shown or described herein.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated.

Various aspects of the disclosure have been described. These and otheraspects are within the scope of the following claims.

What is claimed is:
 1. A method for forming a modular lead, the methodcomprising coiling a plurality of electrical conductors around amandrel, wherein the mandrel is coupled to a conductor hub, wherein theplurality of electrical conductors are mechanically coupled to theconductor hub such that the plurality of electrical conductors are in afixed arrangement relative to one another, wherein coiling the pluralityof electrical conductors includes coiling the plurality of electricalconductors along a length of the mandrel, wherein the plurality ofelectrical conductors extend from a respective plurality of bobbinscoupled to a carriage, the carriage defining a central opening throughwhich the mandrel extends, and wherein coiling the plurality ofelectrical conductors includes moving the mandrel and the carriagerelative to each other angularly and longitudinally, wherein therelative longitudinal movement occurs along a longitudinal axis of themandrel, and such that the carriage moves in a direction away from theconductor hub along the longitudinal axis of the mandrel, and whereinthe relative angular movement occurs such that an orientation of themandrel and an orientation of the carriage rotate relative to eachother.
 2. The method of claim 1, wherein moving the mandrel and thecarriage relative to each other includes rotating the mandrel around thelongitudinal axis of the mandrel and maintaining the orientation of thecarriage.
 3. The method of claim 1, further comprising mechanicallycoupling the plurality of electrical conductors to the conductor hubbefore coiling the conductors around the mandrel.
 4. The method of claim3, wherein mechanically coupling comprises mating each conductor of theplurality of electrical conductors with a respective channel of aplurality of channels extending between a first end of the conductor hubto a second end of the conductor hub.
 5. The method of claim 4, furthercomprising coupling the conductors to the respective channels, whereinthe channels are grooves, and wherein coupling the conductors to therespective channels includes mating the conductors to the respectivegrooves.
 6. The method of claim 1, wherein moving at least one of themandrel and the carriage includes causing the conductors to unwind fromthe bobbins.
 7. The method of claim 6, wherein unwinding the conductorsfrom the bobbins includes controlling an angular velocity of the bobbinsusing a respective plurality of brakes, each bobbin coupled to arespective brake.
 8. The method of claim 6, wherein unwinding theplurality of electrical conductors from the bobbins includes controllinga tension of the conductors using a respective plurality of brakes, eachbobbin coupled to a respective break.
 9. The method of claim 1, furthercomprising coupling the conductor hub with the mandrel before rotatingthe mandrel.
 10. The method of claim 1, wherein the bobbins are coupledto the carriage by positioning the bobbins on the carriage in a radiallysymmetric arrangement on the carriage.
 11. The method of claim 1,further comprising positioning the carriage on a winding apparatus,wherein the winding apparatus includes the mandrel.
 12. The method ofclaim 1, wherein a starting position of the carriage is adjacent to theconductor hub in a direction of a longitudinal axis of the mandrel suchthat the plurality of electrical conductors begin coiling around themandrel adjacent to the conductor hub.
 13. The method of claim 1,further comprising forming an end section of the modular lead aftercoiling the conductors along the length, wherein the conductor hubcomprises a first conductor hub, wherein forming the end section of themodular lead includes coupling a second conductor hub to the pluralityof conductors at the end section.
 14. The method of claim 13, furthercomprising coupling each conductor of the plurality of electricalconductors to a respective channel of a plurality of channels of thesecond conductor hub.
 15. The method of claim 13, wherein coupling thesecond conductor hub to the plurality of electrical conductors includesmaintaining an arrangement of the plurality of electrical conductorsusing a stabilizer hub after coiling the conductors along the length.16. A method for forming a modular lead, the method comprising coiling aplurality of electrical conductors around a mandrel, wherein the mandrelis coupled to a conductor hub, wherein the plurality of electricalconductors are mechanically coupled to the conductor hub such that theplurality of electrical conductors are in a fixed arrangement relativeto one another, wherein coiling the plurality of electrical conductorsincludes coiling the plurality of electrical conductors along a lengthof the mandrel, wherein the plurality of electrical conductors extendfrom a respective plurality of bobbins coupled to a carriage, thecarriage defining a central opening through which the mandrel extends,wherein coiling the plurality of electrical conductors includes movingthe mandrel and the carriage relative to each other angularly andlongitudinally, wherein the relative longitudinal movement occurs alonga longitudinal axis of the mandrel, and such that the carriage moves ina direction away from the conductor hub along the longitudinal axis ofthe mandrel, and wherein the relative angular movement occurs such thatan orientation of the mandrel and an orientation of the carriage rotaterelative to each other, and wherein a starting position of the carriageis adjacent to the conductor hub in a direction of a longitudinal axisof the mandrel such that the plurality of electrical conductors begincoiling around the mandrel adjacent to the conductor hub.
 17. The methodof claim 16, wherein moving the mandrel and the carriage relative toeach other includes rotating the mandrel around the longitudinal axis ofthe mandrel.
 18. The method of claim 17, further comprising coupling theconductor hub with the mandrel before rotating the mandrel.
 19. Themethod of claim 16, further comprising mechanically coupling theplurality of electrical conductors to the conductor hub before coilingthe conductors around the mandrel.
 20. The method of claim 16, furthercomprising forming an end section of the modular lead after coiling theconductors along the length of the mandrel, wherein the conductor hubcomprises a first conductor hub, and wherein forming the end section ofthe modular lead includes coupling a second conductor hub to theplurality of electrical conductors at the end section.
 21. A method forforming a modular lead, the method comprising: coiling a plurality ofelectrical conductors around a mandrel, wherein the mandrel is coupledto a first conductor hub, wherein the plurality of electrical conductorsare mechanically coupled to the first conductor hub such that theplurality of electrical conductors are in a fixed arrangement relativeto one another, wherein coiling the plurality of electrical conductorsincludes coiling the plurality of electrical conductors along a lengthof the mandrel, wherein the plurality of electrical conductors extendfrom a respective plurality of bobbins coupled to a carriage, thecarriage defining a central opening through which the mandrel extends,wherein coiling the plurality of electrical conductors includes movingthe mandrel and the carriage relative to each other angularly andlongitudinally, wherein the relative longitudinal movement occurs alonga longitudinal axis of the mandrel, and wherein the relative angularmovement occurs such that an orientation of the mandrel and anorientation of the carriage rotate relative to each other; and formingan end section of the modular lead after coiling the conductors alongthe length, wherein forming the end section of the modular lead includescoupling a second conductor hub to the plurality of electricalconductors at the end section.
 22. The method of claim 21, furthercomprising coupling each conductor of the plurality of electricalconductors to a respective channel of a plurality of channels of thesecond conductor hub.
 23. The method of claim 21, wherein coupling thesecond conductor hub to the plurality of electrical conductors includesmaintaining an arrangement of the plurality of electrical conductorsusing a stabilizer hub after coiling the electrical conductors along thelength of the mandrel.
 24. The method of claim 21, wherein moving themandrel and the carriage relative to each other includes rotating themandrel around the longitudinal axis of the mandrel.
 25. The method ofclaim 21, further comprising mechanically coupling the plurality ofelectrical conductors to the first conductor hub before coiling theconductors around the mandrel.
 26. The method of claim 21, furthercomprising coupling the first conductor hub with the mandrel beforerotating the mandrel.
 27. The method of claim 21, wherein moving themandrel and the carriage relative to each other includes rotating themandrel around the longitudinal axis of the mandrel and maintaining theorientation of the carriage, and moving the carriage in a direction awayfrom the conductor hub along the longitudinal axis of the mandrel. 28.The method of claim 21, further comprising forming an end section of themodular lead after coiling the conductors along the length, wherein theconductor hub comprises a first conductor hub, wherein forming the endsection of the modular lead includes coupling a second conductor hub tothe plurality of conductors at the end section.
 29. A method for forminga modular lead, the method comprising: coiling a plurality of electricalconductors around a mandrel, wherein the mandrel is coupled to aconductor hub, wherein the plurality of electrical conductors aremechanically coupled to the conductor hub such that the plurality ofelectrical conductors are in a fixed arrangement relative to oneanother, wherein coiling the plurality of electrical conductors includescoiling the plurality of electrical conductors along a length of themandrel, wherein the plurality of electrical conductors extend from arespective plurality of bobbins coupled to a carriage, the carriagedefining a central opening through which the mandrel extends, andwherein coiling the plurality of electrical conductors includes movingthe mandrel and the carriage relative to each other angularly andlongitudinally, wherein the relative longitudinal movement occurs alonga longitudinal axis of the mandrel, and wherein the relative angularmovement occurs such that an orientation of the mandrel and anorientation of the carriage rotate relative to each other; mechanicallycoupling the plurality of electrical conductors to the conductor hubbefore coiling the conductors around the mandrel, wherein mechanicallycoupling comprises mating each conductor of the plurality of electricalconductors with a respective channel of a plurality of channelsextending between a first end of the conductor hub and a second end ofthe conductor hub; and wherein the channels are grooves, and whereinmating each conductor of the plurality of electrical conductors with therespective channel of the plurality of channels includes mating eachconductor of the plurality of electrical conductors to the respectivegrooves.